Novel Adjuvants for Peptide-Based Melanoma Vaccines
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma
Intervention: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine (Biological)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Jeffrey S. Weber, M.D., Ph.D., Principal Investigator, Affiliation: University of Southern California/Norris Cancer Center
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center, Los Angeles, California 90089, United States; Recruiting
Jeffrey S Weber, M.D., Ph.D., Phone: 323-865-3919, Email: jweber@hsc.usc.edu
Additional Information
Starting date: July 2001
Ending date: June 2004
Last updated: June 23, 2005
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