Novel Adjuvants for Peptide-Based Melanoma Vaccines

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028431
• Other study ID #: FD-R-1975-01
• Secondary ID: 10M-00-4;FD-R-00
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2002
• Last updated: May 20, 2014
• Start date: August 2001
• Est. completion date: June 2005

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2005
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States,