NIH Clinical Research Studies

Protocol Number: 08-C-0055

Active Followup, Protocols NOT Recruiting New Patients

Title:
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
Number:
08-C-0055
Summary:
Background:

-gp100 is a peptide (part of 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 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 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.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
Metastatic Melanoma
Immunotherapy
Vaccination
Tumor Regression
Recruitment Keyword(s):
Metastatic Melanoma
Skin Cancer
Condition(s):
Metastatic Melanoma
Skin Cancer
Investigational Drug(s):
(PG13-154-Ecll AIB (anti-gp100:154-162 TCR))
(ALVAC gp100 Vaccine)
Investigational Device(s):
None
Interventions:
Drug: (PG13-154-Ecll AIB (anti-gp100:154-162 TCR))
Drug: (ALVAC gp100 Vaccine)
Supporting Site:
National Cancer Institute

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Kawakami Y, Eliyahu S, Delgado CH, Robbins PF, Rivoltini L, Topalian SL, Miki T, Rosenberg SA. Cloning of the gene coding for a shared human melanoma antigen recognized by autologous T cells infiltrating into tumor.Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):3515-9.

Kawakami Y, Eliyahu S, Sakaguchi K, Robbins PF, Rivoltini L, Yannelli JR, Appella E, Rosenberg SA.Identification of the immunodominant peptides of the MART-1 human melanoma antigen recognized by the majority of HLA-A2-restricted tumor infiltrating lymphocytes.J Exp Med. 1994 Jul 1;180(1):347-52.

Walter EA, Greenberg PD, Gilbert MJ, Finch RJ, Watanabe KS, Thomas ED, Riddell SR.Reconstitution of cellular immunity against cytomegalovirus in recipients of allogeneic bone marrow by transfer of T-cell clones from the donor.N Engl J Med. 1995 Oct 19;333(16):1038-44.

Active Followup, Protocols NOT Recruiting New Patients

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