A Pilot Study of the Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Define the feasibility of generating large doses of MART1/Melan-A specific CTL following leukapheresis in this patient population
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Marcus Butler, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
06-250
NCT ID:
NCT00512889
Start Date:
August 2007
Completion Date:
January 2013
Related Keywords:
- Melanoma (Skin)
- CTL
- MART-1
- Melan-A
- artificial APC
- melanoma
- metastatic melanoma
- adoptive immunotherapy
- adoptive cell transfer
- immunotherapy
- Melanoma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
