Novel Adjuvants for Peptide-Based Melanoma Vaccines - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00028431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Novel Adjuvants for Peptide-Based Melanoma Vaccines

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00028431

Responsible Party

Study ID Numbers ^ICMJE

FD-R-1975-01, 10M-00-4;, FD-R-001975-01

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

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

University of Southern California/Norris Cancer Center

Information Provided By

FDA Office of Orphan Products Development

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP