A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 2007 |
| End Date: | April 2010 |
A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy
This study tests whether denileukin diftitox will deplete regulatory T cells, boost
tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or
who are ineligible for front line therapy.
tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or
who are ineligible for front line therapy.
This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage
epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or
who will not receive such regimens (due to contraindication or intolerance) are eligible.
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response
criteria.
epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or
who will not receive such regimens (due to contraindication or intolerance) are eligible.
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response
criteria.
Inclusion Criteria:
- Able to provide informed consent
- Not on Immune modulating drugs
- Life expectancy less than 6 months
Exclusion Criteria:
- Unable to tolerate phlebotomy
- Germ cell or stromal cell cancers of the ovaries
- Active autoimmune disease
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