PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER

Date de début de l'étude : 1 juillet 1995

DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the colon or rectum with radiologically confirmed metastases or clinically confirmed incurability No hepatic or CNS metastases Progression following fluorouracil (5-FU) alone or with a modulator (e.g., leucovorin, PALA, levamisole, interferon) Measurable disease outside prior radiotherapy fields The following are not considered measurable: Pleural effusion or ascites Osteoblastic lesions or evidence of disease on bone scan alone Progressive irradiated lesions alone Bone marrow involvement Brain metastases Malignant hepatomegaly by physical exam alone Chemical markers (e.g., CEA) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,800/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: No concurrent infection Afebrile for at least 3 days prior to treatment unless fever due to tumor No known HIV infection No other medical condition that precludes protocol participation No second malignancy within 5 years except: Nonmelanomatous skin cancer Curatively treated in situ cervical carcinoma No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women Blood/body fluid analyses within 7 days prior to registration Imaging/exams for tumor measurement within 21 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse-based vaccines or monoclonal antibodies Chemotherapy: At least 2 weeks since prior 5-FU or at least 1 week past the AGC nadir, whichever is later No other prior chemotherapy except irinotecan Endocrine therapy: Not specified Radiotherapy: At least 6 months since radiotherapy Surgery: Not specified