This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a non-randomized, single-arm, multicenter Phase I/II dose-escalation trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable change of cure using standard regimens, or who will not receive such regimens (due to contraindication, intolerance or patient refusal) are eligible. Patients will be dose-escalated in cohorts of five from 12 ug/kg to a maximum of 30 ug/kg in 3 ug/kg increments. Based on the power analysis provided, a final cohort of 36 total patients will be enrolled at the maximum tolerated dose for clinical efficacy testing. Primary endpoints are measured by clinical response rate, disease-free progression, overall survival, toxicities, and tolerability. Secondary end points include immunologic studies. Clinical events will be compared to historical controls. Eligible cancers include epithelial (non-germ cell) cancers of the ovaries and extraovarian peritoneal carcinoma. Patients must have pathologic initial disease confirmation and measurable disease for study entry. Clinically recurrent disease without proven histology is acceptable for this study. This study is designed and powered to detect a 10% or greater response rate (complete plus partial responses).
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