This study looks at a cell therapy for patients with malignant melanoma, in which the patient's own killer immune cells (called CTLs) are grown in the laboratory and given back to help fight the tumor. People with metastatic melanoma expressing MART1/Melan-A and the HLA-A*0201 tissue type could take part. The study was carried out in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with metastatic melanoma: Either unresectable Stage III or any Stage IV * ECOG of 0 or 1 * HLA-A\*0201 haplotype * Baseline tumor biopsy MART1/Melan-A expression present (in \>10% of tumor cells) * Patient provides consent for all required biopsies * Adequate intravenous access for leukapheresis * Absolute lymphocyte count \>500/ul at least once within 30 days of leukapheresis * Life expectancy greater than 4 months in the opinion of the study clinician * Negative pregnancy test Exclusion Criteria: * Administration of systemic corticosteroids within 28 days of planned leukapheresis * Administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis * Administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to Cohort 3 * Active autoimmunity requiring systemic immunosuppressive therapy * HIV infection * Previous enrollment on this protocol and infusion of MART1/Melan-A CTL