vaccine therapy in treating patients with metastatic cancer

Conditions: Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: stage iv melanoma recurrent melanoma unspecified adult solid tumor, protocol specific