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Title
Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK Administered with Advanced Stage Ovarian Cancer
 
Study Design
Patients will receive intraperitoneal ONTAK for 3 consecutive days every 14 days, which defines one cycle. Each patient will be treated for 4 cycles, but may receive up to 8 cycles if no disease progression occurs.
 
Study Contact
Stephanie Parker | 866.932.8588 | E-Mail
 
Patient Population
  1. Patients with advanced-stage ovarian cancer
  2. Unable to achieve a first complete remission with first or second line chemotherapy, or have disease relapse after achieving a second complete remission
Number of Patients: This study will accrue a maximum of 13 patients into 3 dosing levels.
(Now accruing for the last does level
 
Patients Visits

  1. Up to 22 visits in Seattle if 4 treatment cycles are given; up to 40 visits if 8 cycles are given
  2. Total of 4 cycles with potential for up to 8 cycles
  3. Ontak administered 3 consecutive days every 14 days (classifed as one cycle)
  4. Follow-up visits 7 and 14 days after the final treatment cycle
  5. Blood collection at Months 1, 2, 3, and 6 after treatment, which may occur at patients’ home clinics if this is more convenient
Other Procedures

  1. History & Physical
  2. Labs
  3. CT Scans
  4. Clinical Evaluations
  5. Research Blood Draws
  6. Intraperitoneal Washes
Objectives
Primary:
  1. Safety
  2. Immune Response
Other Notes
Since the ONTAK in this study is given intraperitoneally, patients will need to have an intraperitoneal catheter suitable for infusion before enrolling in the study.
ONTAK® is FDA Approved
ONTAK® (Denileukin diftitox) is used to treat patients with a persistent or recurrent cutaneous T-cell lymphoma. ONTAK® is not FDA approved to treat ovarian cancer.
ONTAK® (Denileukin diftitox) is a Biologic Response Modifier Agent
Denileukin diftitox is a fusion protein (a combination of diphtheria toxin and interleukin-2) which selectively delivers the cell-killing activity of the diphtheria toxin to targeted cells.
 
Start Date: October 2001
 
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
 
Current Enrollment: 56%
 
Scientific Description
 
ClinicalTrials.gov Identifier: NCT00357448
 
Page last updated 01/26/2012