Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
stage IV melanoma, recurrent melanoma, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.
Detailed description
OBJECTIVES: * Determine whether an immunologic response can be obtained in HLA\*0201-expressing patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51. * Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients. * Determine the toxicity of this treatment in these patients. * Determine whether prior immunization with telomerase: 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma. OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of three treatment arms. * Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment. * Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3 hours at baseline, after the vaccine on week 4, and after each course of treatment. * Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in arm II. Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course of treatment after achieving CR. Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum) will be accrued for this study within less than 2 years.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALincomplete Freund's adjuvant
BIOLOGICALtelomerase: 540-548 peptide vaccine
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Presenting with evaluable metastatic cancer * Refractory to standard treatment OR * Post-radiation for malignant glioma * HLA-A\*0201 expression PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months 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 * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No cardiac ischemia by stress thallium or comparable test\* * No prior myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*Patients receiving interleukin-2 (IL-2) only Pulmonary: * No obstructive or restrictive pulmonary disease (patients receiving IL-2 only) Immunologic: * HIV negative * No autoimmune disease or any other known immunodeficiency disease * No active primary or secondary immunodeficiency Other: * No other active major medical illness\* * No active systemic infection * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception NOTE: \*Patients receiving IL-2 only PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior telomerase: 540-548 peptide immunization Chemotherapy: * Recovered from prior chemotherapy Endocrine therapy: * No requirement for systemic steroid therapy Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since prior systemic therapy for cancer
Countries
United States
Outcome results
None listed