Melanoma (Skin) Clinical Trial
Official title:
Randomized Comparison of Three Schedules of Peptide Immunization in Patients With Stage II or III, or Completely Resected Metastatic Melanoma
Verified date | March 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine
therapy may be an effective treatment for melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy
regimens in treating patients who have melanoma.
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of melanoma, including one of the following characteristics: - Lesions at least 1.5 mm in thickness - At least 1 positive lymph node - Ulcerated lesion - Local recurrence - Metastatic lesions completely resected within the past 6 months - Clinically disease free within the past 6 weeks - HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual 11/05/01) - No ocular or mucosal melanoma PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 90,000/mm^3 Hepatic: - Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome) - AST and ALT less than 3 times normal - Hepatitis B surface antigen negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - For interleukin-2 (IL-2) therapy: - No cardiac ischemia, myocardial infarction, or cardiac arrhythmias - Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or arrhythmia, or older than 50 years Pulmonary: - For IL-2 therapy: - No obstructive or restrictive pulmonary disease - FEV_1 greater than 60% predicted if prolonged history of cigarette smoking or symptoms of respiratory dysfunction Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No active systemic infections, autoimmune disease, or active primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior systemic biologic therapy for melanoma - No prior gp100 antigen or tyrosinase or TRP-1 peptide - No other concurrent systemic biologic therapy for melanoma Chemotherapy: - At least 3 weeks since prior systemic chemotherapy and recovered - No concurrent systemic chemotherapy for melanoma Endocrine therapy: - At least 3 weeks since prior systemic endocrine therapy for melanoma - No concurrent systemic steroid therapy Radiotherapy: - At least 3 weeks since prior systemic radiotherapy and recovered - No concurrent systemic radiotherapy for melanoma Surgery: - See Disease Characteristics |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Rosenberg SA, Sherry RM, Morton KE, Scharfman WJ, Yang JC, Topalian SL, Royal RE, Kammula U, Restifo NP, Hughes MS, Schwartzentruber D, Berman DM, Schwarz SL, Ngo LT, Mavroukakis SA, White DE, Steinberg SM. Tumor progression can occur despite the inductio — View Citation
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