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

Phase 1
18 Years
Not Enrolling
Melanoma (Skin)

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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:


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:


Principal Investigator

Marcus Butler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




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



Dana-Farber Cancer InstituteBoston, Massachusetts  02115