Radiation, Chemotherapy, Vaccine and Anti-MART-1 and Anti-gp100 Cells for Patients With Metastatic Melanoma
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Background:
- Melanoma antigen recognized by T-cells (MART-1) and gp100 are two genes found in
melanoma cells. An experimental procedure developed for treating patients with advanced
melanoma uses these genes and a type of virus to make special cells called anti-MART-1
and anti-gp100 cells, which are designed to destroy the patient's tumor. The cells are
created in the laboratory using the patient's own tumor cells or blood cells.
- The procedure also uses one of two vaccines-the anti-MART-1 peptide or the anti-gp100
peptide-to stimulate cells in the immune system that may increase the effectiveness of
the anti-MART-1 and anti-gp100 cells. Both vaccines are made from a virus that is
modified to carry a copy of the MART-1 gene or gp100 gene. The virus cannot cause
disease in humans.
Objectives:
- To evaluate the safety and effectiveness of anti-MART-1 and anti-gp100 cells and peptide
vaccines for treating patients with advanced melanoma.
Eligibility:
- Patients 18 years of age with metastatic melanoma for whom standard treatments, including
aldesleukin (IL-2) therapy to boost immune response, have not been effective.
Design:
- Participants have an initial evaluation with complete medical history, as well as scans,
x-rays, and other tests as directed by researchers. Most of the treatments for this
study will be given on an inpatient basis.
- Before the treatment begins, participants will undergo leukapheresis (removal of
selected blood cells) to obtain cells for preparing the anti-MART-1 and anti-gp100
cells, and for later stem cell transplantation.
- Preinfusion treatment: 5 days of chemotherapy and 2 days of total-body irradiation to
prepare the immune system for receiving the anti-MART-1 and anti-gp100 cells.
- Infusion of cells, followed by IL-2 treatment to improve immune response. IL-2 is given
as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses (over 5
days).
- After the cell infusion, participants will be divided into two groups and will receive
either the gp100 peptide or MART-1 vaccine, given once a week for 3 weeks. Participants
will also have stem cell transplantation (from previously collected stem cells) to
promote cell survival.
- Periodic follow-up clinic visits after hospital discharge for physical examination,
review of treatment side effects, laboratory tests and scans every 1 to 6 months.