Clinical trial · Interventional
Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer
Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK® Administered to Patients With Advanced Stage Ovarian Cancer
NCT00357448CI-TRIAL-00038588completedPhase 1ClinicalTrials.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)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mixed Epithelial Carcinoma | — | UNRESOLVED | — |
| Ovarian Mucinous Cystadenocarcinoma | Ovarian Mucinous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Cystadenocarcinoma | Ovarian Serous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Undifferentiated Adenocarcinoma | — | UNRESOLVED | — |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| denileukin diftitox | Biological | — | UNRESOLVED |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| intraperitoneal administration | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: denileukin diftitox
- Procedure: intraperitoneal administration
- Other: laboratory biomarker analysis
- Other: enzyme-linked immunosorbent assay
- Other: flow cytometry
Primary outcomes (2)
- measure
- Safety and toxicity profile as assessed by the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events version 3.0
- timeFrame
- From baseline
- measure
- MTD
- timeFrame
- From baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDLiao JB, Jejurikar NS, Hitchcock-Bernhardt KM, Gwin WR, Reichow JL, Dang Y, Childs JS, Coveler AL, Swensen RE, Goff BA, Disis ML, Salazar LG. Intraperitoneal immunotherapy with denileukin diftitox (ONTAK) in recurrent refractory ovarian cancer. Gynecol Oncol. 2024 Dec;191:74-79. doi: 10.1016/j.ygyno.2024.09.019. Epub 2024 Oct 2. PMID 39362046