RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating
patients who have metastatic cancer that has not responded to previous therapy.
OBJECTIVES: I. Determine the toxicity profile of MAGE-12 peptide vaccine in patients with
refractory metastatic cancer that expresses MAGE-12 antigen.
II. Determine whether an immunologic response, as measured by an in vitro sensitization
assay, can be obtained after administration of this regimen in these patients.
III. Determine a frequency of administration for this regimen based on immunologic response
in these patients.
IV. Determine other immunologic parameters in these patients treated with this regimen.
V. Determine the clinical response rate in these patients treated with this regimen.
PROTOCOL 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 two
Arm I: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant
subcutaneously (SC) weekly for 4 doses.
Arm II: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC
once every 3 weeks for 4 doses.
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8
hours, beginning on the day after each immunization and continuing for up to 4 days.
Patients achieving stable disease or a mixed, partial, or complete response continue on
vaccine therapy alone for up to 24 total doses.
Patients are followed at 3 weeks.
A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 1
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically documented metastatic cancer of one of the
following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell
lung cancer Breast carcinoma Sarcoma HLA-Cw*0702 positive MAGE-12 expression by RT-PCR
amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No
renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy--
Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other
concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior
chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine
therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal
therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior
radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior
surgery for cancer allowed --Patient Characteristics-- Age: 16 and over Sex: Male or
female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal
Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia,
myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy)
Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy)
Other: Not pregnant Negative pregnancy test Fertile patients must use effective
contraception No active systemic infections No autoimmune disease, known immunodeficiency
disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen
negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy)