Ovarian Cancer Clinical Trial
Official title:
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.
This study is a prospective, single-arm phase I trial of 20 ovarian cancer patients to be
treated with PISH for 6 cycles, delivered every 28 days. This mimics chemotherapy treatments,
in concordance with the fractional cell kill hypothesis of cytotoxic agents.
As this study is for safety, only, metastatic peritoneal or ovarian cancer, of any histology
(epithelial, sex-cord stromal, germ cell, or sarcoma) that has progressed after 2 cycles of
chemotherapy, and is considered incurable, will be included. All patients must meet
performance status and organ function entry criteria. Patients must have first undergone
standard first line primary surgery and chemotherapy, and have then gone on to fail second
line chemotherapy treatment, (with or without secondary cytoreductive surgeries). Patients
must be candidates for, and expecting treatment by, the usual third line chemotherapy agent
palliation traditionally offered by medical oncology. Patients may have received treatment
beyond third-line therapy, as long as they meet entry requirements for this study.
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