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open access:
Interim analysis of a phase I/IIa trial assessing E39+GM-CSF, a folate binding protein vaccine, to prevent recurrence in ovarian and endometrial cancer patients
Patient characteristics and clinical protocols
This study is a prospective phase I/IIa dual-center trial being conducted under BB-IND #12391. Eligible patients were identified with primary or recurrent endometrial, ovarian, fallopian tube or peritoneal cancer and were disease-free after standard of care therapies. Patients were surgically or naturally post-menopausal. Exclusion criteria included patients currently receiving immunosuppressive therapy to include chemotherapy, steroids or methotrexate, poor health (ECOG > 2), evidence of end-organ dysfunction, pregnancy, breast feeding, history of autoimmune disease, and involvement in other experimental protocols (except with permission of the principal investigator of the other study).....
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