Novel Adjuvants for Peptide-Based Melanoma Vaccines
Completed · Phase 1
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT00028431
- Run by
- University of Southern California
- People needed
- 19
- Starts
- 2001-08-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2014-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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