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Therapeutic Areas: Oncology
Disease Category: Mesothelioma

Trial Information

Phase II trial of combined resection, intraperitoneal chemotherapy, and whole abdominal radiation for treatment of peritoneal mesothelioma.

Patients will be adults who have histologically confirmed malignant abdominal mesothelioma and will have received 0-2 prior chemotherapeutic regimens. Referral from the consultation service may take place only with the agreement of the responsible attending physician.

All patients will undergo exploratory laparotomy. An attempt will be made to remove all nodules of greater than 1 cm in diameter. Approximately three to four weeks following surgery, intraperitoneal chemotherapy will be initiated weekly for twelve weeks. Following the intraperitoneal chemotherapy, patient will receive intraperitoneal immunotherapy weekly for four weeks.

Afterward, patients will undergo a second operation similar to first, where the abdomen will be re-inspected for any remaining or re-growing tumor. A single treatment with heated chemotherapy drugs (cisplatin/mitomycin) will be washed through the abdominal cavity for 90 minutes and the port-a-cath will be removed. If tumor remains in the abdomen after these treatments, patients will be removed from the study.

Patients will then receive 5 weeks of radiation therapy (Monday through Friday) directed to the whole abdomen. This will complete the treatment.

Patient Inclusion/Exclusion Criteria:

Prior therapy allowed:

• 0-2 prior chemotherapy regimens; greater than 6 weeks since chemotherapy
• Greater than 1 week since surgery (prior surgical resection preceding disease recurrence is acceptable)
• No prior abdominal or lower chest radiation therapy

Non pregnant, non lactating

Clinical Parameters:

• Life expectancy greater than 2 months
• Age greater than 18 years
• Performance status 0-2 (SWOG)

Required initial laboratory data:

• White cell count greater than 3000/ul
• Platelet count greater than 100,000/ul
• Calculated creatinine clearance greater than or equal to 45 ml/min
• Bilirubin less than 1.5 x normal

Dr. Robert Taub is the Principal Investigator.

Elethea Hare, MSPA, RPA-C
Columbia University Medical Center
Herbert Irving Cancer Center of Columbia University
161 Fort Washington Avenue
New York NY 10032
Phone: 212-305-1252
Fax: 212-305-6891
EMail: eh2344@columbia.edu

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