Clinical Research

This is a listing of Loyola University Health System clinical research that is open and actively recruiting patients. Please click on the name of the research for a brief description, eligibility requirements and contact information. All research listed below have been approved by Loyola's Institutional Review Board chairman for promotion on our Web site.

For more information call (888) LUHS-888.

A Multicenter, Open Registry of Patients With Psoriasis Who Are Candidates for Systemic Therapy Including Biologics, Protocol Number: C0168Z03
The registry study will track the behavior of the disease in response to other therapies, such as adalimumab, alefacept, certolizumab pegol, efalizumab, etanercept and other biologics. The registry also will evaluate clinical outcomes, quality of life and potential risks for patients who may receive standard therapies for psoriasis.

A Multicenter, Open Registry of Patients with Psoriasis Who Are Candidates for Systemic Therapy Including Biologics, Protocol Number: C0168Z03. Submission of protocol including amendment 1 dated 07 Aug 2007, participant materials (appointment card reminder), marketing tools (poster, thank you cards, postcard), questionnaires (employment/productivity health economic questionnaire, dermatology QOL, hospital anxiety and depression scale (HADS 1 and 2), EQ-5D health questionnaire and scale.

An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001. Submission of protocol dated 7/9/09, clarification memo dated 7/15/09, diary cards, script for the DVD for patient teaching, appointment cards reminders, instructions for removing and replacing the hose-barb connector on the invacare mobilarie compressor, and advertising brochure.
To provide access to CIS treatment to subjects previously enrolled in the APT study CIS001 or to subjects screened for CIS001 but not enrolled due to an SAE persisting beyond post-transplant day 70;To assess the long-term safety of CIS administration;To collect data on extended follow up and survival in lung transplant patients treated with CIS;To assess the long-term safety of CIS administration via the recording of serious adverse events and local respiratory adverse events associated with study drug administration during the titration phase.

The Efficacy of Culture Directed Intravenous Antibiotic Therapy in the Treatment of Patients with Chronic Sinusitis. Submission of protocol (version 1), The Smell Identification Manual and source documents that contain copies of the questionnaires that need to be completed by the participants.

Arthritis

An Open-label, Randomized Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab (TCZ) Monotherapy or TCZ in Combination With Non-biologic DMARDs in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic or Biologic DMARDs, Protocol Number ML22533
The purpose of this study is to assess the safety and tolerability of TCZ monotherapy or TCZ in combination with one or more of the approved background non-biologic disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current non-biologic or biologic DMARDs.

C87094: A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis.
To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12 ;Secondary Objectives • To assess for all patients at Week 12:The clinical response rate as measured by American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) ;Secondary Objectives • To assess for all patients at Week 12:The reduction of disease activity by DAS28(CRP) [Disease Activity Score – 28 (C-reactive protein)], SDAI [Simplified Disease Activity Index] and CDAI [Clinical Disease Activity Index] (1,2) ;Secondary Objectives • To assess for all patients at Week 12: • The achievement of clinical remission (by DAS28(CRP), SDAI and CDAI) ;Secondary Objectives • To assess for all patients at Week 12: • The improvement in individual components of the ACR criteria, including tender joint count (TJC), swollen joint count (SJC), Health Assessment Questionnaire-Disability Index (HAQ–DI), CRP, Patient’s Assessment of Arthritis Pain-Visual Analog Scale (VAS), Patient’s Global Assessment of Disease Activity-VAS and Physician’s Global Assessment of Disease Activity-VAS.;Secondary Objectives • To assess for all patients at Week 12: • Time to sustained ACR20 response ;Secondary Objectives • To assess for all patients at Week 12: • European League Against Rheumatism (EULAR) response ;Secondary Objectives • To assess for all patients at Week 12: • The tolerability and safety of certolizumab pegol (CZP) therapy

Phase III, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Two Doses of CP-690,550 in Patients With Active Rheumatoid Arthritis on Background DMARDS, Study Number: A3921046
This study is designed to provide one year of safety data and pivotal efficacy data in support of the proposed United States claims of reducing signs and symptoms and improvement in physical function for CP-690,550, dosed at 5 and 10 mg BID in patients with RA who have had an inadequate response to a DMARD (traditional or biologic), and similar claims within other jurisdictions. Patients must remain on at least one stably dosed, background traditional DMARD other than a potent immunosuppressive (such as azathioprine or cyclosporine) and must have washed out of all potent immunosuppressives and biologic response modifiers.

Bladder Health

Nocturia and Chronic Medical Illness
To determine whether the severity of nocturia is related to renal function, glucose control and fluid intake, in samples of patients with and without diabetes mellitus. The use of this data may help to develop a valid, clinically useful algorithm for the evaluation and treatment of patients with nocturia.

UITN ValUE ( Value of Urodynamic Evaluation)
To determine if women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only without preoperative urodynamic studies ( No UDS arm) have non-inferior treatment outcomes compared to women who receive both office evaluation and preoperative UDS (UDS arm).

Cancer

Assessment of Health Behaviors in Cancer Survivors
To assess the nutritional and health habits of cancer survivors.

Cancer: Breast

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-positive Ductal Carcinoma In Situ Resected by Lumpectomy
The purpose of this study is to determine the value of trastuzumab given during radiation therapy compared to radiation therapy alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.

A Randomized Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
The purposes of this study are to compare the pathologic complete response (pCR) rates in patients randomized to bevacizumab versus no bevacizumab, to compare the overall survival of patients randomized to the bevacizumab arm versus no bevacizumab and to explore molecular biomarkers related to biology and outcome of inflammatory breast cancer.

NSABP B-40, A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens
The purpose of this study is to determine whether the addition of bevacizumab to docetaxel with or without capecitabine or gemcitabine then AC, will increase the rate of pathologic complete response in the breast (pCR breast) relative to docetaxel then AC with or without bevacizumab and to determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel then AC, docetaxel/capecitabine then AC and docetaxel/gemcitabine then AC) will increase the rate of pCR breast relative to the same docetaxel/anrthracycline-based regimens without bevacizumab.

Cancer: Head and Neck

A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent Or Metastatic Head and Neck Cancer
The purpose of this study is: • To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard cisplatin-based chemotherapy with or without bevacizumab. • To assess toxicities with the addition of bevacizumab to each cisplatin-doublet (cisplatin/docetaxel and cisplatin/5-FU). • To compare the objective response rates and the progression-free survival achieved with the above therapies. • To collect blood samples before and after therapy for future correlative studies. • To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies.

Cancer: Lung

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without COncurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Protocol S0819 Version Date: 7/29/09
The primary objective of this study is:
In patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare: a. Overall survival (OS) in the entire study population b. Progression-free survival (PFS) by institutional review in EGFR FISH-positive patients
The secondary objectives are:
In patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare: a. OS and PFS by centralized review in EGFR FISH-positive patients b. PFS by centralized image review and by institutional review in the entire study population
To compare the response rate (confirmed plus unconfirmed, complete and partial responses) in the subset of patients with measurable disease in: a. EGFR FISH-positive patients b. The entire study population
To assess the toxicities of these treatment regimens
To prospectively test EGFR FISH as a predictive marker for the selection of patients for cetuximab plus chemotherapy
To evaluate the role of KRAS mutations in terms of cetuximab efficacy
To compare the results of EGFR FISH with KRAS mutations, EGFR mutations, EGFR IHC and other purported EGFR-related biomarkers

Cancer: Melanoma

A Randomized, Double-blind, Placebo-controlled, Phase Two Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma.
The primary objective of the study is to assess if the addition of ABT-888 to temozolomide (TMZ) can prolong PFS compared to TMZ alone in subjects with metastatic melanoma (MM).
The secondary objectives of the study will be to determine overall survival, one-year survival rate, six-month progression-free survival rate, response rate, disease control rate, duration of overall response, quality of life, safety and tolerability and time to neurological/brain progression.

Cancer: Multiple Myeloma

Phase I/II Study Utilizing High Dose Busulfan and Melphalan Followed by Escalating Bortezomib as Conditioning in Autologous Peripheral Blood Stem Cell Transplantation for Participants With Multiple Myeloma
The purpose is to evaluate efficacy as measured by response rate through a phase I/II non-randomized trial that utilizes a preparative regimen consisting of intravenous busulfan plus melphalan, both at standard dosages, followed by escalating doses of bortezomib, supported by transplantation of autologous hematopoietic stem cells.

Cancer: Ovarian

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-Sensitive Ovarian Cancer in First Relapse
The purpose of this study is to assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS) as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse.

Cancer: Bone

A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
The primary objective of this study is to prospectively assess the cumulative incidence of osteonecrosis of the jaw (ONJ) at three years in cancer participants with bone metastasis receiving zoledronic acid treatment.

Cancer: Brain

RTOG -0525 A Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
The purpose of this study is to determine if dose-intensifying adjuvant temozolomide during chemoradiation treatment enhances treatment efficacy as measured by overall survival.

Cancer: Breast

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
To evaluate hemorrhage toxicities resulting from early vs later addition of bevacizumab to patients receiving cisplatin/etoposide and radiotherapy followed by consolidation docetaxel/bevacizumab in patients with unresectable Stage III non small cell lung cancer

A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
To compare disease-free survival and overall survival in participants with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus weekly trastuzumab (12 weeks) followed by a six-week treatment-free interval followed by lapatinib (34 weeks) versus trastuzumab in combination with lapatinib for one year. To evaluate the safety and tolerability of all four treatment groups.

AA Phase Ib/II, Open-Label Study of the Safety, Tolerability, and Efficacy of Trastuzumab-MCC-DM1 in Combination with Pertuzumab Administered Intravenously to Participants with HER2-Positive, Locally Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Prior Therapy
To characterize the safety and tolerability of the combination of T-DM1 and pertuzumab administered every 3 weeks to participants with HER2-positive locally advanced or metastatic breast cancer who have previously received trastuzumab in any line of therapy, have received chemotherapy combined with HER2-targeted therapy for advanced disease, and have progressed while receiving their most recent therapy.

Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) For Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer.
Primary: To compare the effect, in terms of progression free survival, of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with ER and/or PgR positive advanced breast cancer.

Phase II Study to Evaluate Efficacy and Safety of Adjuvant High-Dose Rate Brachytherapy (delivered using the mammosite applicator) as the Sole Method of Radiation Therapy for Selected Women with Stage I Breast Cancer-Small Volume DCIS
The study seeks to test whether radiation to part of the breast using brachytherapy after the removal of cancer gives similar results to those obtained when the whole breast receives RT. The study also seeks to assess safety of the mammosite device in this setting, including the quality of life.

Phase II study of Carboplatin, Nanoparticle Albumin-bound Paclitaxel (ABI-007) and Bevacizumab (Avastin) as the first line therapy in metastatic breast cancer.
The purpose of this study is to determine the progression free survival of this regimen in the first line metastatic breast cancer setting.

Phase III Randomized Trial of Anastrozole vs. Anastrozole and Fulvestrant as First-Line Therapy for PostMenopausal Women with Metastatic Breast Cancer
The study seeks to compare the time to tumor progession in postmenopausal women with metastatic breast cancer treated with anastrozole vs. anastrozole and fulvestrant as first-line therapy.

Phase III Trial of Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
The purpose of this study is to determine the best hormonal treatment for premenopausal women. Patients are randomized to tamoxifen, tamoxifen plus ovarian suppression function (OFS) or exemestane plus OFS.

RTOG 0413 NSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Radiation vs. Partial Breast Radiation for Women with Stage 0, I or II Breast Cancer
The purpose of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.

Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib or Both as Neoadjuvant Treatment of HER2-positive Primary Breast Cancer
The purpose of this study is to determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib or to neoadjuvant weekly paclitaxel plus lapatinib (THL) is 20 percent greater than the pCR to weekly paclitaxel with trastuzumab alone (TH) in HER2-positive operable breast cancer.

Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane-induced Neuropathy, Phase III
To assess if Acetyl-L-Carnitine (ALC) as compared to a placebo prevents symptoms of taxane-related neuropathy as measured by an 11-item neurotoxicity component of the FACT-Taxane at 12 weeks after registration in patients treated with adjuvant taxanes for breast cancer.

SWOG S0230 Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer
The purpose is to compare the rate of premature ovarian failure at two years following standard adjuvant chemo with/without ovarian supression with LHRH analog during chemo in premenopausal women with early stage, hormone-receptor negative breast cancer.

Targeting Notch Signaling and Hepatocyte Growth Factor in Breast Cancer
To analyze tumor specimens from breast cancer participants in order to further elucidate mechanisms of cancer stem cell activation and inhibition.

Cancer: Cervical or Endometrial

RTOG 0418 A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-Operative Patients with Either Endometrial or Cervical Carcinoma
The purpose of this study is to determine the transportability of IMRT to a multi-institutional setting, and to test the hypothesis that there is a reduction in short-term bowel injury with this regimen compared to standard treatments. Adverse events related to this treatment regimen will be assessed. The rates of local regional control, distant metastasis, disease free and overall survival will be evaluated. Chemotherapy compliance with this regimen for the cervical carcinoma patients will observed.

Cancer: Cervix

A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet Topotecan Plus Paclitaxel With and Without NCI-Supplied Bevacizumab in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
The purpose of this study is to determine whether the addition of bevacizumab to chemotherapy improves overall survival and to determine if a regimen involving paclitaxel and topotecan improves overall survival in comparison to a regimen involving cisplatin and paclitaxel. Another purpose of this study is to determine and compare the frequency and severity of adverse events for the regimens administered in this study

Cancer: Colon

A Phase II study of AMG 655 in Combination with Modified Folfox6 and Bevacizumab for First-Line Treatment of Subjects with Metastatic Colorectal Cancer
The purpose of this study is to help us understand which dose of the investigational drug in combination with a standard of care chemotherapy called mFOLFOX6 (which includes a modified dose of 5-fluorouracil [5-FU], oxaliplatin, and leucovorin) and bevacizumab, can be safely given to humans and produce a desired result. This study will explore how effective the investigational drug is in treating colorectal cancer.

Cancer: Colorectal

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly-diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
To evaluate the efficacy of pegfilgrastim as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature = 38.0°C (= 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24-hour window of a temperature = 38.0°C or (= 100.4°F).

Cancer: Gallbladder or Bile Duct

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC).
The purpose of this study is to estimate the stratum-specific (RO and R1) and overall two-year survival probabilities of EHCC participants treated with adjuvant capecitabine/gemcitabine followed by capecitabine and radiotherapy.

Cancer: Kidney (Renal)

Mechanistic Evaluations of Sorafenib-induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma (RCC)
The purpose of this study is to better understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The effect of sorafenib treatment on the heart’s ability to pump blood efficiently also will be studied.

Cancer: Leukemia

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Participants Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
The primary objective of this study is to test whether the induction regimen incorporating azacitidine and gemtuzumab ozogamicin is sufficiently safe and effective among older participants with previously untreated AML to warrant phase III study.

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
The purpose of this study is to determine patient outcomes following high dose combination chemotherapy treatment and to compare higher dose vincristine with compared to standard dose vincristine

Cancer: Lung

A PHASE II TRIAL OF THE COMBINATION OF OSI-774 (ERLOTINIB; NSC-718781) AND BEVACIZUMAB (RHUMAB VEGF; NSC-704865) IN NEVER-SMOKERS WITH STAGE IIIB AND IV PRIMARY NSCLC ADENOCARCINOMAS
The primary objective of this Phase II study is to assess overall survival in never-smokers with primary lung adenocarcinomas.

A Phase II Study of Oligometastatic Stage IV Non-small Cell Lung Cancer (NSCLC) Treated with Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
The purpose of this study is to assess whether the addition of radiation therapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival in all eligible Stage IV NSCLC patients.

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)
This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur. The purpose of this study is to determine if adding bevacizumab to chemotherapy improves the chance for cure for participants who have had complete surgical resection of their Stage IB-IIIA NSCLC.Bevacizumab is considered investigational drug in this study.

A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
The purpose of this study is to evaluate the efficacy of weekly topotecan as a single agent and the combination of AVE0005 and weekly topotecan in previously treated platinum-sensitive and platinum refractory patients with extensive stage small cell lung cancer (E-SCLC) in terms of progression-free survival (PFS) at three months.

Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer (E5597 Phase III)
The purpose of this study is to find out if a high selenium yeast tablet can prevent lung cancers in participants following surgical removal of a Stage I Non Small Cell Lung Cancer

OSI-774-302 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Erlotinib Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-positive Tumors.
The primary objectives of this study are to assess the efficacy of single-agent, oral, once daily erlotinib at 150 mg/day following complete surgical resection and to assess for an increase in DFS in patients with EGFR-positive tumors.

Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol >25 pg/mL
The investigational drug for this study is paclitaxel poliglumex (CT-2103). CT-2103 is a chemotherapeutic agent that links paclitaxel (chemotherapy agent) to amino acids. Once CT-2103 is inside a cell, proteins in the cell break down CT-2103 releasing paclitaxel.

Cancer: Lymphoma

A Multicenter Phase II Study Incorporating Doxil and Rituximab into the Magrath Regimen for HIV-Negative and HIV-Positive Patients with Newly Diagnosed Burkitt’s and Burkitt-like Lymphoma
The primary objective of this study is to evaluate the response rate for patients with Burkitt’s and Burkitt-like lymphoma

A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
The purpose of this study is to estimate the two year progression-free survival in patients with advanced stage Hodgkin lymphoma treated with response-adapted therapy based on FDG-PET imaging after two cycles of ABVD.

A Phase II, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid) in Participants with Mantle Cell Non-Hodgkin’s Lymphoma Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib.
To determine the tumor response and duration of response of lenalidomide monotherapy in participants with Mantle Cell Non-Hodgkin’s Lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.
To evaluate the safety of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.
To determine the CR, time to progression, time to treatment failure, progression-free survival and overall survival of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.

A Phase III, Randomized, Double Blind Study of Galiximab in Combination with Rituximab compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma.
The primary purpose is to compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for relapsed or refractory follicular non-Hodgkin's lymphoma.

A pivotal study of SGN-35 in treatment of patients with relapsed or refractory lymphoma (ALCL)
Primary objective is to determine the antitumor efficacy of single-agent SGN-35 as measured by the overall response rate in patients with relapsed or refractory systemic ALCL.

An Intensive QT/QTc Companion Study to Investigate the Effects of SGN-35 on Cardiac Ventricular Repolarization in Patients With Cancer
The purpose of this study is to evaluate the effect of treatment with SGN-35 on cardiac ventricular repolarization in cancer patients.

CALGB 50303/CTSU50303 Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas
The purpose of this study is to compare the effects of two treatments; R-CHOP with Dose-Adjusted EPOCH-R for untreated de novo DLBC lymphoma and to develop molecular predictor of outcome using molecular profiling.

Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response BMT CTN PROTOCOL 0701
The primary objective of this study is to measure progression-free survival at two years after non-myeloablative HSCT with a pre-transplant conditioning regimen of fludarabine, cyclophosphamide and rituximab (FCR).

S0350 A Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell non-Hodgkin’s Lymphoma
To estimate the 2-year overall survival of patients with peripheral T-cell non-Hodgkin’s Lymphoma (NHL) treated with a regimen of cisplatin, etoposide, gemcitabine, and solumedrol (PEGS). To assess toxicity, response rate (complete unconfirmed, complete and partial responses), and progression-free survival in patients treated with this regimen

S0801 A Phase II Study of Iodine-131 Labeled Tositumomab in Combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy For Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma
To evaluate response rate and toxicity in participants with advanced stage follicular NHL treated with R-CHOP + I-131 tositumomab with rituximab maintenance; to estimate the three-year and five-year progression-free survival rate; to assess the safety profile of rituximab maintenance following the R-CHOP + I-131 tositumomab regimen.

Temsirolimus for Relapsed/Refractory Hodgkins Lymphoma
The primary objective of this study is to estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus, evaluate the toxicity of temsirolimus in this patient population, estimate the time to progression and overall survival after treatment with temsirolimus

Cancer: Prostate

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal-related Events in Men With Prostate Cancer to Bone
The purpose of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal-related event.

Cancer: Rectal

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
The purpose of this study is to assess the pathologic complete response rate in participants with adenocarcinoma of the rectum, Stages II and III with wild-type K-ras treated with the combination of oxaliplatin, capecitabine and cetuximab given alone and given concomitantly with external beam radiation (EBRT), followed by surgery.

Cancer: Skin (Melanoma)

A Phase 2 Study of AZD0530 in metastatic melanoma
The purpose of this phase 2 study is to evaluate AZD0530 in treating metastatic melanoma.

A Phase I Dose Escalation Trial of Dendritic Cell-Based Vaccination for Stage IV Melanoma Patients.
The purpose of the study is to assess the dose limiting toxicity for dendritic cells pulsed with autologous tumor lysate and matured using a Dendritic Maturation Cocktail composed of IL-1 beta, IL-6, TNF alpha, and PGE2, injected intranodally with KLH in Stage IV melanoma patients.

Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
The purpose of this study is to find out what effects (good and/or bad) SCH 727965 has on your patients and their Stage IV melanoma. SCH 727965 is an experimental drug. It can affect the cancer's cell cycle (the process in which cells divide and reproduce). Other studies have shown that it might be able to control the growth of some cancers. This study is being done to see if this drug can control the growth of melanoma tumors to a point where it can help people live longer.

Cancer: Soft Tissue Sarcoma

A Multinational, Randomized, Double-Blind Placebo Controlled Study of AVE8062 Administered Every 3 Weeks, in Patients with Advanced-Stage Soft Tissue Sarcoma Treated with Cisplatin After Failure of Anthracycline and Ifosfamide Chemotherapies.
To compare the progression-free survival, overall survival and the objective response rate in the two treatment arms. To assess the safety profile of AVE8062 (in combination with cisplatin). To assess the pharmacokinetics of AVE8062 and its main metabolite RPR258063, using a population approach, in all patients enrolled in selected centers. To assess genotypes of drug metabolizing enzymes in all enrolled patients in blood sampling collected before the first study drug infusion.

Cancer: Uterine

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
The purpose of this study is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to pelvic radiation therapy.

Cardiovadiovascular Health: Arrhythmia

Multidisciplinary Study of Right Ventricular Dysplasia (ARVD)
This is a multidisciplinary, multicenter collaborative study to investigate the cardiac, clinical and genetic aspects of arrhythmogenic right ventricular dysplasia (ARVD). The primary goal is to identify 100 patients with definite ARVD and their family members. The study offers a substantial prospect of expanding the fund of clinical knowledge regarding ARVD and/or localizing the genetic mutation(s) responsible for this disorder.

Cardiovascular Health

Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA Trial)
The CABANA trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation. The CABANA trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated atrial fibrillation.

Cardiovascular Health: Aortic Valve

An Observational, Prospective Evaluation of the Trifecta Valve
This observational cohort study will assess the clinical safety and effectiveness of aortic valve replacement (using the Trifecta valve) by prospectively recording adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.

Cardiovascular Health: Atherosclerosis

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events
The purpose of this study is to test the safety and effectiveness of SCH 530348 when used with standard medications. Complications of atherosclerosis can occur when a blood clot forms rapidly in an artery causing a more severe blockage and decrease in blood flow. The study drug is an antiplatelet medication.

Cardiovascular Health: Diabetes

Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease
The study seeks to evaluate whether percutaneous coronary intervention(PCI) with drug-eluding stenting (PCI/DES) is more or less effective than the existing standard of care, coronary artery bypass surgery (CABG).

Cardiovascular Health: Heart Failure

Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritede in Subjects with Decompensated Heart Failure (ASCEND-HF)
The primary objective is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of heart failure re-hospitalizations and all-cause Mortality through 30 days after randomization or heart failure symptoms (as measured by subject self-assessed Likert dyspnea scale at 6 and 24 hours after study drug initiation) compared with placebo when each is administered in addition to other standard therapies in subjects with acute decompensated heart failure.

Cardiovascular: Marfan Syndrome

Aortic Valve Operative Outcomes in Marfan Patients
The purpose of the study is to: -Evaluate and compare operative outcomes of the aortic valve-sparing (AVS) and aortic valve replacement (AVR) surgical interventions in different categories of patients with Marfan syndrome and estimate predictors of the surgical outcomes; - Compare the outcomes described in above objective in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Determine predictors that have prognostic importance for the outcomes of surgical interventions in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Evaluate prevalence of different types of AVR and AVS operations in patients with Marfan syndrome who had surgical intervention for correction of aortic valve abnormalities; - Evaluate indications used to perform AVR and AVS operations in patients with Marfan syndrome; - In different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention, estimate: a) short-term morbidity & mortality in patients with Marfan syndrome undergoing the AVS or the AVR surgical intervention; b) cumulative incidence of selected complications estimated from the 24 month follow-up period; c) freedom from selected complications estimated from the 24 month follow-up period; d) survival rate estimated from the 24 month follow-up period; e) Quality of life score Develop a centralized on-line database for accumulation of data on patients with Marfan syndrome undergoing the AVS or the AVR surgery; - Develop a repository for blood and tissue samples obtained from study participants.

Cardiovascular: Peripheral Vascular Disease

Use of TRC Autologous Bone Marrow Cells in Patients with Peripheral Arterial Disease to Treat Critical Limb Ischemia
The purpose of this clinical research is to determine if bone marrow cells that are harvested from a patient's bone and expanded can be used as a method for treatment of critical limb ischemia in patients with peripheral artery disease.

Diarrhea

A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR 101 Taken q12h with 125 mg Vancomycin Taken q6h for 10 Days in Subjects with Clostridium Difficile-associated Diarrhea
The study seeks to compare the effectiveness and safety of the investigational study drug, PAR 101, with vancomycin in the treatment of clostridium difficile-associated diarrhea (CDAD).

Endocrinology: Diabetes

Diabetes Type 2 & Exenatide Observational Study
The purpose of this study is to collect information on how the medication exenatide is being used to treat people with type 2 diabetes. We will study the effectiveness of exenatide in improving blood sugar control.

Vitamin for Metabolic Control and Depressive Symptoms in Women with Diabetes
The purpose of this study is to determine whether taking vitamin D supplementation will help with metabolic control (fasting blood sugar, insulin resistance, HBA1c) and depressive symptoms.

Endocrinology: Growth Hormone

The Global Hypopituitary Control and Complications Study (HypoCCS)
The primary objective of the study is to determine whether long-term growth hormone (GH) replacement therapy administered in clinical practice to adults with growth hormone deficiency (GHD) is associated with increased or decreased incidences of clinically significant adverse events (AEs).

Heart Disease: Atrial Fibrillation

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation.(ARISTOTLE: Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) Protocol CV185030.
The purpose of this study is to determine if the investigational drug is noninferior to warfarin in the combined endpoint of stroke and systemic embolism. The investigational drug is an oral active inhibitor of the coagulation factor Xa (FXa) to be used as an anticoagulant and antithrombotic agent.

Mental Health: Depression

Cardiovascular Risk Biomarkers During Quetiapine Antidepressant Treatment
The purpose of this study is to investigate quetiapine’s ability to reverse those pathophysiological changes occurring in depression and anxiety that have been linked causally to the development of cardiovascular disease.
Arterial stiffness will be measured non-invasively by a procedure called applanation tonometry. The measures serve as markers of subclinical hardening of the arteries and may be able to show a response to therapy, if such hardening is present. The procedure involves positioning of a probe on the skin overlaying certain arteries in the body, namely the radial, carotid and femoral. Heart rate variability similarly is determined non-invasively by placing three leads on the chest and determining heart function. Treatment with quetiapine is expected to restore normal heart function.

Non-invasive pulse-wave analysis to test endoethelial function in depressed subjects.
The purpose of this study is to evaluate endothelial function in patients diagnosed with Major Depressive Disorder (MDD) using applanation tonometry to compute pulse wave velocity and index of augmentation.

Neurosciences

Cardiovascular Risk Biomarkers During Quetiapine Antidepressant Treatment
To investigate quetiapine’s ability to reverse those pathophysiological changes occurring in depression and anxiety that have been linked causally to the development of cardiovascular disease.

Pulmonary embolism

An International, multicenter, randomized, double-blind, double-dummy, parallel group, study of three- or six-month treatment with SSR126517E versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis.
The purpose of this study is to compare the safety and effectiveness of biotinylated idraparinux or avidin with the standard treatment of pulmonary embolism (warfarin).

Sinus Health

Balloon Remodeling Antrostomy Therapy Study (BREATHE I) Study
1. To evaluate the safety and feasibility of the device in treating subjects with rhinosinusitis in the maxillary, or maxillary and anterior ethmoid sinuses2. To study the feasibility of treating the subjects under local anesthesiaduring the study procedure

Skin Health: Psoriasis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis, Protocol Number: M10-315.
The purpose of this study is to gauge the safety and effectiveness of ABT-874 versus etanercept in patients with moderate to severe chronic plaque psoriasis.

AA Multicenter, Open Registry of Patients with Psoriasis Who Are Candidates for Systemic Therapy Including Biologics, Protocol Number: C0168Z03
The registry study will track the behavior of the disease in response to other therapies, such as adalimumab, alefacept, certolizumab pegol, efalizumab, etanercept, and other biologics. The registry will also evaluate clinical outcomes, quality of life, and potential risks for patients who may receive standard therapies for psoriasis

CLINICAL STUDY PROTOCOL P10-023 A 10-Year, Post-marketing, Observational, Registry of Adalimumab in Adult Patients.
The purpose of this registry is to observe the degree of long-term safety of adalimumab and how well it works to treat chronic plaque psoriasis for up to ten years. Adalimumab is a marketed drug for psoriasis. No medication is provided for this registry.

Observational Post-Marketing Safety Surveillance Registry of Etanercept for Treatment of Psoriasis
The purpose of this study is to continue to gather and evaluate information on the long-term safety of etanercept in a large number of participants with plaque psoriasis.

Stroke

Albumin in Acute Stroke (ALIAS) Trial: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
Neuroprotective agents for acute ischemic stroke have thus far failed to be proven effective. Albumin versus placebo is the next step in trying to find a valid treatment for stroke victims.

Carotid Occlusion Surgery Study (COSS)
The COSS study hopes to determine if EC/IC bypass surgery is better for patients with TIA/stroke who also have an occluded carotid artery versus best medical therapy.

Insulin Resistance Intervention after Stroke (IRIS) Trial
Pioglitazone is a medication given to diabetics from blood glucose control. It has not been tested versus placebo for the overall risk of decreasing fatal/non-fatal stroke or fatal/non-fatal MI among non-diabetic men and women with insulin resistance.

The Experience of Family Caregivers of Stroke Survivors
The purpose of this study is to describe how female caregivers of stroke survivors cope with the stress of care-giving.

Transplant: Heart

A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0g MMF with standard dose Neoral in de novo heart transplant recipients.
The purpose of this study is to examine the impact of Certican with reduced Neoral dose on efficacy and renal function relative to a standard comparator of MMF with standard dose of Neoral.

Transplant: Lung

A Multi-center, Randomized, Controlled Study to Demonstrate theEfficacy and Safety of Cyclosporine Inhalation Solution (CIS) inImproving Bronchiolitis Obliterans Syndrome-Free SurvivalFollowing Lung Transplantation
In order to improve long-term survival following lung transplantation, efforts must focus on preventing the development of chronic lung rejection. The objective of this study is to establish the efficacy and safety of inhaled cyclosporine (CIS) in preventing chronic rejection in lung transplant patients. This research study will help to confirm whether or not CIS, in addition to other medications that suppress the immune system, will help to prevent new lung(s) from being rejected by the body’s natural immune system.

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
This research study will help to confirm whether or not CIS, in addition to other medications that suppress the immune system, will help to prevent new lung(s) from being rejected by the body’s natural immune system.

Women's Health: Prolapse and Bladder Control

Operations and Pelvic Training in the Management of Apical Support Loss: The Optimal Trial
The OPTIMAL study has two purposes: 1) To compare two standard surgical techniques [sacrospinous ligament fixation (SSLF) and uterosacral ligament (USLS)] for apical vaginal prolapse regardless of the presence of a uterus, and 2) To determine the utility of perioperative pelvic muscle exercises and behavioral on postoperative bladder and bowel symptoms after surgery.

cancer

An Open Label, Double Arm, Single Center Pilot Study to Evaluate the Safety and Efficacy of Transplantation of either StemEx®, Umbilical Cord Blood (UCB) Stem and Progenitor cells Expanded Ex vivo, or an Unmanipulated Cord Blood Unit in the Elderly Population with Hematologic Malignancies using a Reduced Intensity Regimen.
To assess the safety of StemEx® vs unmanipulated UCB transplantation following RIC regimen in the elderly population on overall 100 day survival. To assess the efficacy of StemEx® vs. unmanipulated UCB transplantation following RIC regimen in the elderly population on full donor chimerism at Day 100.