Novel Adjuvants for Peptide-Based Melanoma Vaccines

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, December 2001

First Received: January 4, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00028431

Purpose

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

Condition	Intervention	Phase
Melanoma	Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Immunoglobulins Ipilimumab Cytotoxic T-lymphocyte antigen 4 Tyrosinase Globulin, Immune

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	72
Study Start Date:	July 2001
Estimated Study Completion Date:	June 2004

Detailed Description:

In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma
Completely resected disease or disease-free
HLA-A2.1 positive
Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens
At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy
WBC count at least 3,000/mm3
Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 gm/dL
Creatinine no greater than 2.0 mg/dL
Bilirubin no greater than 2.0 mg/dL
SGOT/SGPT no greater than 2.5 times upper limit of normal
ECOG performance status 0-1
Have failed alpha-interferons (patients with resected stage III disease)

Exclusion criteria:

Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides
Steroid therapy or other immunosuppressive medication requirement
Major systemic infections (e.g., pneumonia or sepsis)
Coagulation or bleeding disorders
Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems
Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant)
History of uveitis or autoimmune inflammatory eye disease
Other active autoimmune disease
Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
Pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028431

Locations

United States, California
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90089
Contact: Jeffrey S Weber, M.D., Ph.D. 323-865-3919 jweber@hsc.usc.edu

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

Jeffrey S. Weber, M.D., Ph.D.

University of Southern California/Norris Cancer Center

More Information

No publications provided

Study ID Numbers:	FD-R-1975-01, 10M-00-4;, FD-R-001975-01
Study First Received:	January 4, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00028431 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Stage III melanoma
Stage IV melanoma
Interleukin-12
Cancer Vaccines
Antineoplastic Agents, Combined
Incomplete Freund's adjuvant
Monophenol Monooxygenase

Mannitol
Adjuvants, Immunologic
Melan-A Protein
Antigens, Neoplasm
Antibodies
Melanocyte lineage-specific antigen gp100
CTLA-4

Additional relevant MeSH terms:

Neuroectodermal Tumors
Antibodies
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Germ Cell and Embryonal

Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pharmacologic Actions
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009