PHASE I STUDY OF INTERFERON ENHANCED INTRAPERITONEAL RADIOIMMUNO-CHEMOTHERAPY FOR OVARIAN CANCER

Date de début de l'étude : 1 mars 1996

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of extraovarian origin Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens (with or without paclitaxel), i.e.: persistent disease or progression after chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent carcinoma (after primary or secondary chemotherapy) detected clinically either by exam or rising CA 125 and with radiographic evidence of disease no greater than the equivalent of 5 x 5 x 5 cm nodules Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy Microscopic residual disease on reassessment laparotomy after chemotherapy Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor blocks At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m scan or other imaging within 2 weeks prior to treatment No evidence of disease outside the peritoneal cavity other than retroperitoneal lymphadenopathy No massive ascites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 WBC at least 3,500/mm3 Platelet count at least 125,000/mm3 Hemoglobin greater than 9 g/dL No nucleated RBC or significant teardrop RBC morphology Bilirubin less than 1.5 mg/dL AST/ALT less than 4 times normal Creatinine less than 2.0 mg/dL HIV negative Hepatitis B surface antigen negative No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan No other malignancy in past 5 years except basal cell skin carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: At least 3 weeks since prior biologic therapy and recovered No prior monoclonal antibody therapy No concurrent immunotherapy No prior bone marrow or stem cell transplantation At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No concurrent chemotherapy At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to the abdominal cavity No concurrent radiotherapy At least 3 weeks since prior major surgery and recovered No prior intraperitoneal therapy