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
18 Years
N/A
Both
Melanoma
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Jeffrey S. Weber, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Southern California/Norris Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
FD-R-1975-01
NCT ID:
NCT00028431
Start Date:
July 2001
Completion Date:
June 2004
Related Keywords:
- Melanoma
- 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
- Melanoma
Name | Location |
|---|---|
| Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center | Los Angeles, California 90089 |
