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

Melanoma (Skin) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00512889
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 1
• Start date: August 2007
• Completion date: January 2013