Cancer

Title
Adoptive Immunotherapy Trial to Study Effectiveness of Genetically Engineered T cells in patients with melanoma.
Trial Number
203732
Number of Participants
15
Principal Investigator

Michael Nishimura

Ph.D.
Surgical Research
Professor
Eligibility

-Participants be 18 years of age and must have a diagnosis of metastatic melanoma, which is measurable either clinically or radiologically and normal cardiac ejection fraction (EF >50%) as determined by a screening echocardiogram.
-Participants must have a performance status of 0 or 1 ECOG PS scale
-Participants’ melanoma must be positive for both tyrosinase and HLA-A2 per Loyola pathologic review from FNA/core/excisional biopsy of lesion.
-Participants who have undergone treatment with anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) antibody must be off of CTLA-4 antibody for at least three months before they can be enrolled into this study.
-The participant’s BRAF mutation status at position 600 must be known prior to enrollment. Participants with V600E mutations are eligible if they have failed vemurafenib therapy or have been offered vemurafenib therapy and refused.
-Participants treated with prior Interleukin-2 will be allowed to be in this study.

Purpose

The purpose of this study is to determine the number of TIL 1383I TCR transduced T cells that can be given without producing serious problems. We also want to learn about the side effects that these cells can cause, how well the cells are tolerated and the effects of these cells on your cancer.

Enrollment

(708) 327-3221

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