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: May 20, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 20, 2014
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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014