vaccine therapy in treating patients with refractory metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: randomized phase ii trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.

objectives: * determine whether an immunologic response can be obtained after administration of eso-1 peptide vaccine comprising class i , ii, or both peptides in hla-a\*201 or hla-dpb1\*04 positive patients with refractory metastatic melanoma expressing eso-1. * determine the toxicity of this vaccine in these patients. * determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2. outline: patients are assigned to 1 of 3 groups according to hla type. * group 1 (hla-a\*201 and hla-dpb1\*04 positive): patients receive eso-1 peptide vaccine comprising class i (eso-1:157-165 \[165v\]) and class ii (eso-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. * group 2 (hla-a\*201 positive and hla-dpb1\*04 negative):patients receive eso-1 peptide vaccine as in group i comprising class i peptide only. * group 3 (hla-a\*201 negative and hla-dpb1\*04 positive):patients receive eso-1 peptide vaccine as in group i comprising class ii peptide only. patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (il-2) iv over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). treatment with il-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity. patients who have stable disease or a mixed or partial response to vaccination or il-2 therapy may be eligible for additional vaccine therapy. patients who have a complete response to vaccine therapy are eligible for 1 additional treatment. patients are followed at 3 weeks. projected accrual: a total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic melanoma that expresses eso-1 antigen * must have progressed during prior standard treatment * measurable or evaluable disease * hla-a\*201 or hla-dpb1\*04 positive 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: * sgot and sgpt less than 3 times normal * bilirubin no greater than 1.6 mg/dl (3.0 mg/dl for patients with gilbert's syndrome) * hepatitis b surface antigen negative renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no cardiac ischemia\* * no myocardial infarction\* * no cardiac arrhythmias\* note: \*for interleukin-2 (il-2) administration pulmonary: * no obstructive or restrictive pulmonary disease (for il-2 administration) immunologic: * no autoimmune disease * no active primary or secondary immunodeficiency * hiv negative * no active systemic infections other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no other active major medical illness (for il-2 administration) prior concurrent therapy: biologic therapy: * no prior eso-1 immunization chemotherapy: * recovered from any prior chemotherapy endocrine therapy: * no concurrent systemic steroid therapy radiotherapy: * recovered from any prior radiotherapy surgery: * not specified other: * at least 3 weeks since any prior systemic therapy for cancer * no other concurrent systemic therapy for cancer

Keywords: recurrent melanoma stage iv melanoma