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Clinical Trials associated with ALVAC gp100 Vaccine(NCI)Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization
Background:
gp100 is a protein that is often found in melanoma tumors.
An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 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) gp100, made from a virus that ordinarily infects canaries and is modified to carry a copy of the gp100 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 gp 100 cells.
Objectives:
-To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in treating patients with advanced melanoma.
Eligibility:
-Patients 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 gp100 cells.
Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of gp100 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.
100 Clinical Results associated with ALVAC gp100 Vaccine(NCI)
100 Translational Medicine associated with ALVAC gp100 Vaccine(NCI)
100 Patents (Medical) associated with ALVAC gp100 Vaccine(NCI)
100 Deals associated with ALVAC gp100 Vaccine(NCI)