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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

January 4, 2002
May 20, 2014
August 2001
January 2003   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00028431 on ClinicalTrials.gov Archive Site
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Novel Adjuvants for Peptide-Based Melanoma Vaccines
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2005
January 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028431
FD-R-1975-01, 10M-00-4;, FD-R-001975-01
Not Provided
University of Southern California
University of Southern California
Not Provided
Principal Investigator: Jeffrey S. Weber, M.D., Ph.D. University of Southern California/Norris Cancer Center
University of Southern California
May 2014

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