Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma
Status:
Terminated
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
Background:
- Melanoma antigen recognized by T-cells (MART)-1 is a protein present in melanoma cells.
- An experimental procedure developed for treating patients with melanoma uses the
anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5
cells that are designed to destroy the patient's tumor. These cells are created in the
laboratory using the patient's own tumor cells or blood cells.
- The treatment procedure also uses a vaccine called plaque purified canarypox vector
(ALVAC) MART-1, made from a virus that ordinarily infects canaries and is modified to
carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot
cause disease in humans. When the vaccine is injected into a patient, it stimulates
cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells.
Objectives:
-To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating
patients with advanced melanoma.
Eligibility:
-Patients 18 years of age with metastatic melanoma for whom standard treatments have not been
effective.
Design:
- Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells
for laboratory treatment.
- Patients have 7 days of chemotherapy to prepare the immune system for receiving the
anti-MART-1 F5.
- Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and interleukin-2 (IL-2) (an
approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an
infusion through a vein. The vaccine is given as injections just before the infusion of
anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion
every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses.
- After hospital discharge, patients return to the clinic for periodic follow-up with a
physical examination, review of treatment side effects, laboratory tests and scans every
1 to 6 months.