Status:
COMPLETED
Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 sid...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose of intraperitoneal administration of ONTAK. SECONDARY OBJECTIVES: I. To evaluate the change in the number of Tregs in the peritoneum with ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00357448
Start Date
April 1 2005
Last Update
May 14 2019
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109