A Pilot Study of the Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Define the feasibility of generating large doses of MART1/Melan-A specific CTL following leukapheresis in this patient population
Marcus Butler, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|