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Home > "N" Clinical Trials Conditions > Novel Adjuvants for Peptide-Based Melanoma Vaccines  Novel Adjuvants for Peptide-Based Melanoma Vaccines
Novel Adjuvants for Peptide-Based Melanoma Vaccines
For Condition: Melanoma
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Principal Investigator, University of Southern California/Norris Cancer Center
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center *Recruiting*
Los Angeles, California, 90089
United States
Recruiting Jeffrey Weber 323-865-3919
Additional Information:
Study ID Numbers: FD-R-1975-01; 10M-00-4;,FD-R-001975-01
Study Start Date: July 2001
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028431
Other Melanoma Studies:
1. A Phase III Multi-Institutional Randomized Study of Immunization with the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma
2. Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
3. Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
4. Microarray Analysis for Human Genetic Disease
5. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Novel Adjuvants for Peptide-Based Melanoma Vaccines
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