Melanoma Clinical Trial
Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
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.
Full Description
DETAILED OUTLINE: This is an early phase pilot/feasibility trial.
Study subjects will be sequentially accrued to three cohorts. Cohorts 1 and 2 will evaluate the safety and feasibility of infusing two different doses of CTL.
Participants in all cohorts will undergo two CTL infusions 5 weeks apart.
Procedures performed during the trial will include physical examinations, laboratory tests, delayed hypersensitivity testing, and skin biopsies.
Between 5 and 8 days after the first CTL infusion, a biopsy or excision of a melanoma lesion may be performed.
Three leukapheresis procedures will be performed: two to collect peripheral blood for CTL production and one for research purposes at the end of the clinical trial.
Radiology tests (including CT scans) will be performed prior to infusion and about 4-5 weeks after the second CTL infusion.
Eligibility 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
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There is 1 Location for this study
Boston Massachusetts, 02115, United States
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