Protocol Number: 02-C-0106

Title:

An Open-Label Study of MDX-CTLA4 in Combination with gp100 Peptides Emulsified with Montanide ISA 51 in the Treatment of Patients with Stage IV Melanoma

Number:

02-C-0106

Summary:

This study will examine the safety and effectiveness of an experimental vaccine given with an immune booster to treat advanced melanoma. The vaccine contains peptides (pieces of proteins) of two gp100 proteins, which are produced by melanoma tumors. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptides. The vaccine will be given along with CTLA-4 antibody, an immune booster.

Patients 16 years of age and older with melanoma that has spread from the primary site and does not respond to standard treatment may be eligible for this study. Candidates will be screened with a physical examination, eye examination, blood tests, electrocardiogram, and imaging studies (x-rays and scans) to check the size and extent of tumor, and lung function tests, if medically indicated. Because the vaccine formulation is based on tissue type, only patients with tissue type HLA-A*0201 may participate. Tissue type is determined by a blood test.

Participants will receive CTLA-4 antibody, administered intravenously (IV) over 90 minutes through a catheter (plastic tube) placed in a vein. They will then be given four injections of the peptide vaccines in the thigh. The vaccination plus antibody treatments will be given four times-once every 3 weeks. Participants will have blood tests and physical examinations at each clinic visit to measure CTLA-4 antibody levels and look for changes in the blood that signal reactions to the vaccine or antibody, and to check for side effects. During the first injection of CTLA-4 antibody and for 6 hours after, six small blood samples will be taken to measure levels of the antibody. Once a day for 3 days after the first vaccine injection, and once a week for the next 3 weeks, a nurse will call the patient at home to check health status and drug side effects.

Patients will also undergo plasmapheresis-a procedure to collect quantities of white blood cells-before treatment begins and possibly again 3 weeks after the second and fourth vaccinations. For this procedure, blood is drawn through a needle in the arm and circulated through a machine that spins it to separate the components. The white cells are removed and the plasma and red cells are returned to the patient through a needle in the other arm. Some patients may also have a biopsy of normal skin and tumor or lymph node tissue to examine the effects of the vaccine on the tumor immune cells. This involves drawing a small amount of tissue through a needle put in the skin.

Patients will return to the clinic 3 weeks after the fourth vaccination for a follow-up examination and blood tests. Patients who experience severe side effects to the vaccine or develop an immune reaction against CTLA-4 antibody, or whose condition worsens with treatment, may be taken off the study. Patients whose disease has not progressed or whose tumor has shrunk may receive another course of four vaccinations, with continued follow-up if the disease improves.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

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

Disease Category:

PROTICD

Keywords:

CTLA-4

Immunotherapy

Clinical Response

Human Monoclonal Antibody

Pharmacokinetics

Recruitment Keywords:

Melanoma

Conditions:

Melanoma

Investigational Drug(s):

MDX-CTLA-4

Montanide ISA 51

GP 100: 280-288 (288V)

gp100:209-217 (210M)

Investigational Device(s):

None

Contacts:

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.

Citations:

Lang PG Jr. Malignant melanoma. Med Clin North Am. 1998 Nov;82(6):1325-58. Review. PMID: 9889751

Duran Garcia E, Santolaya R, Requena T. Treatment of malignant melanoma. Ann Pharmacother. 1999 Jun;33(6):730-8. Review. PMID: 10410188

Chen L, Ashe S, Brady WA, Hellstrom I, Hellstrom KE, Ledbetter JA, McGowan P, Linsley PS. Costimulation of antitumor immunity by the B7 counterreceptor for the T lymphocyte molecules CD28 and CTLA-4. Cell. 1992 Dec 24;71(7):1093-102.

PMID: 1335364

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/21/2004