NCT00357448 - Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

November 30, 2009

Conditions

Fallopian Tube CancerOvarian Clear Cell CystadenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mixed Epithelial CarcinomaOvarian Mucinous CystadenocarcinomaOvarian Serous CystadenocarcinomaOvarian Undifferentiated AdenocarcinomaPeritoneal Cavity CancerRecurrent Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial Cancer

Interventions

BIOLOGICAL

denileukin diftitox

Given IP at 3 dose levels: 5mcg/kg of ONTAK, 15mcg/kg of ONTAK, or 25mcg/kg of ONTAK

PROCEDURE

intraperitoneal administration

After completion of I.P. normal saline infusion, the I.P. catheter will be capped and patients will be turned/rotated for 1 hour to help facilitate I.P. bathing w/ONTAK; patients will be turned/rotated every 15 minutes in 4 different positions for a total of 1 hour

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

enzyme-linked immunosorbent assay

Correlative studies

OTHER

flow cytometry

Correlative studies

Trial Locations (1)

98109

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Washington

OTHER