Clinical Research Details

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.

202080091609

60

-Patients must be = 18 years of age.
-Patients must have biopsy-proven malignant melanoma of cutaneous or mucosal origin.
-Patients with ocular melanoma are not eligible. Patients must have Stage IV disease as outlined in Section 4.0. NOTE: Patients with unknown primary are eligible.
-Patients must be offered participation in the submission and banking of tissue for future use.
-Patients may have measurable or non-measurable disease.
-All measurable lesions must be assessed (by physical examination, CT or MRI scan) within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 42 days prior to registration. The CT from a combined PET/CT must not be used to document measurable disease unless it is of diagnostic quality.
-All patients must undergo a CT or MRI of the brain within 42 days prior to registration that is negative for brain metastases. Patients with a history of brain metastases are ineligible.
-Patients must have a Zubrod Performance Status of 0 - 1.
-Patients may have received up to one (zero or one) prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy or a combination regimen) for Stage IV melanoma excluding prior therapy with a cdk inhibitor. Any side effects the patients had due to prior systemic therapy must have resolved to = Grade 1 prior to registration.
-Patients may have received any number of prior adjuvant systemic therapy regimens, including interferon alpha 2b, GM-CSF, chemotherapy and chemobiotherapy. Therapy for Stage IV resected free of disease will be considered adjuvant therapy.
-Patients may have received prior radiation therapy. Any side effects the patients had due to prior radiation therapy must have resolved to = Grade 1 prior to registration.
-Patients may have received prior surgery (for both the primary and Stage IV disease). Any side effects the patients had due to prior surgery must have resolved to = Grade 1 prior to registration.

You will receive SCH 727965 intravenously (through a needle into your vein) once every three weeks in this study. This three-week period of time is called a cycle.

Joseph Clark, M.D.

(708) 327-3221