Novel Adjuvants for Peptide-Based Melanoma Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00028431
First received: January 4, 2002
Last updated: September 20, 2013
Last verified: September 2013
  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 1

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


Further study details as provided by University of Southern California:

Enrollment: 19
Study Start Date: August 2001
Study Completion Date: June 2005
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Jeffrey S. Weber, M.D., Ph.D. University of Southern California/Norris Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00028431     History of Changes
Other Study ID Numbers: FD-R-1975-01, 10M-00-4;, FD-R-001975-01
Study First Received: January 4, 2002
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
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:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Antibodies
Cytotoxic T-lymphocyte antigen 4
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 23, 2014