Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer

Completed · Phase 1

Conditions studied: Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

In brief

RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox in treating patients with advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian tube cancer.

Key facts

Study ID

NCT00357448

Run by

University of Washington

People needed

11

Starts

2005-04-01

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or epithelial fallopian tube carcinoma
• Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, transitional cell carcinoma, and mixed epithelial carcinoma
• Patients with advanced stage refractory ovarian carcinoma: patients unable to achieve first complete remission (CR) with first or second line chemotherapy OR patients with disease relapse after achieving second CR
• Patients must be 30 days out from last chemotherapy; previous chemotherapy must include a platinumbased regimen and paclitaxel (Taxol)
• Patients must have undergone primary debulking surgery
• Patients must have a peritoneal catheter suitable for I.P. infusion
• White blood cell count (WBC) > 3.0 THOU/ul
• Serum creatinine =< 2.5 mg/dL
• ALT =< 2.5 x upper limit of normal
• AST =< 2.5 x upper limit of normal
• Total bilirubin =< 2.0 x upper limit of normal
• Albumin >= 3.0 g/dL
• Subjects must have a Performance Status Score (Zubrod/SWOG Scale) =< 2
• Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
• Lymphocytes > 1.0 THOU/ul
• Platelets >= 100 THOU/ul

You may not qualify if…

• Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2
• Known history of hypersensitivity to diphtheria toxin or IL-2
• Moderate (symptomatic requiring the use of diuretics) or severe (symptomatic requiring paracentesis or other invasive intervention) ascites
• Active autoimmune disease
• Known history of pulmonary disease except controlled asthma
• Known history significant cardiac disease
• Concurrent malignancy requiring active treatment
• Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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