CTCA initiates Phase I/II ovarian cancer trial

The Phase I/II study, recently reviewed and cleared by the FDA, will evaluate the safety and efficacy of the unique ovarian cancer vaccine therapy for up to 42 patients with chemotherapy-resistant, advanced stage ovarian cancer.

The study will be conducted exclusively at Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center in suburban Chicago. Eligible participants will be CTCA patients who have stage III or IV ovarian cancer and have tumor progression despite at least one, but no more than two, chemotherapy regimens.

Participants in this clinical trial must first receive surgery at CTCA at Midwestern Regional Medical Center and localized chemotherapy infused directly into the abdomen (intraperitoneal chemotherapy), a standard of cancer care available to many CTCA patients. Patients become eligible for the ovarian cancer vaccine trial when it is determined that enough tumor cells can be harvested from the debulked tumor to create the ovarian cancer vaccine and the vaccine has passed rigid quality control testing.

CTCA will work with Avax Technologies to create a personalized ovarian cancer vaccine, using each patient’s tumor cells that have been surgically removed at CTCA. These cells will be modified in the Avax laboratories and will be designed to produce an immunologic response to treat the patient’s ovarian cancer.

Donald Braun, CTCA vice president for clinical research, said: “The use of a systematic vaccine to sensitize the patient’s immune system to fight their own tumors following localized, high-dose chemotherapy has not been attempted before.”