Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight infections and cancer. These CTL can be manipulated in the laboratory so that they can target an individual's cancer.

PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own immune cells are collected by a procedure called a leukapheresis. The cells then undergo laboratory processing for three weeks. Part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. These extra genes are to "teach" the participant's own immune cells to become anti-tumor CTL that can attack the melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute

Criteria

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