Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon may interfere with the growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Interferon-alpha; Interferons; Paclitaxel; Topotecan

Criteria

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