Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen

CDR0000068173

RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells. 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.

2000-07-01

Early phase I

-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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'primaryPurpose': 'TREATMENT'}}

2024-03-04