Clinical trial · Interventional
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
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
NCT00880360CI-TRIAL-00032249ONTAKcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Extraovarian Peritoneal Cancer | — | UNRESOLVED | — |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ontak | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ontak
- description
- Administration of Ontak IV for treatment of epithelial ovarian cancer
- interventionNames
- Drug: Ontak
Primary outcomes (1)
- measure
- Number of Participants Demonstrating Clinical Response
- timeFrame
- 2 years
- description
- Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.