vaccine therapy in treating patients with stage iv melanoma

Conditions: Melanoma (Skin)

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

objectives: * determine the feasibility of treating patients with stage iv melanoma with d1/3-mage-3-his fusion protein with sb-as02b adjuvant. * determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen. * determine the 6-month progression-free survival rate of patients treated with this regimen. * determine the qualitative and quantitative toxic effects of this regimen in these patients. * determine immune responses in patients treated with this regimen. outline: this is a multicenter study. patients receive d1/3-mage-3-his fusion protein emulsified in sb-as02b adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). in the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16. patients are followed every 3 months for 1 year and then every 6 months for 2 years. projected accrual: a total of 25-45 patients will be accrued for this study within 5-9 months.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion * m1a or m1b disease * measurable disease outside prior field of limb perfusion * metastatic mucosal melanoma allowed * mage-3 positive by reverse transcription polymerase chain reaction * no uveal or choroidal primary melanoma * no prior or concurrent brain metastases by ct scan or mri of the brain patient characteristics: age * not specified performance status * zubrod 0-1 life expectancy * not specified hematopoietic * not specified hepatic * hepatitis b surface antigen negative * hepatitis c negative * no liver cirrhosis * no unstable liver disease * no coagulation disorders renal * not specified cardiovascular * no major cardiovascular illness * no myocardial infarction within the past 6 months pulmonary * no major pulmonary illness other * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no aids or hiv-1-associated complex * no chronic alcohol abuse or drug addiction * no systemic infections * no prior active autoimmune disease * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer from which the patient is currently disease-free prior concurrent therapy: biologic therapy * at least 4 weeks since prior adjuvant biologic therapy * no prior biologic therapy for stage iv melanoma * no prior mage-3 peptide or protein vaccine preparation chemotherapy * at least 4 weeks since prior adjuvant chemotherapy * no prior chemotherapy for stage iv melanoma endocrine therapy * not specified radiotherapy * at least 4 weeks since prior adjuvant radiotherapy surgery * at least 4 weeks since prior surgery other * see disease characteristics * at least 3 weeks since prior limb perfusion and recovered * at least 4 weeks since other prior adjuvant therapy * no other prior therapy for stage iv melanoma

Keywords: stage iv melanoma recurrent melanoma