Clinical trial · Interventional
Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis
NCT00003439CI-TRIAL-00009344completedPhase 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)
Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease, patient may receive up to 9 additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity.
- interventionNames
- Biological: recombinant interleukin-12
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed intraabdominal cancer * Diffuse abdominal carcinomatosis Chemotherapy refractory advanced stage ovarian cancer * Measurable disease * Residual, recurrent, or metastatic disease beyond the scope of standard curative therapy * Extension of disease to sites distant to the peritoneal cavity allowed Retroperitoneal lymphadenopathy allowed as long as there is evaluable intraabdominal disease * No history of progressive brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: Karnofsky 70-100% * Hemoglobin greater than 9 g/dL * WBC greater than 3,000/mm3 * Platelet count greater than 100,000/mm3 * Bilirubin less than 2.0 mg/dL * ALT less than 100 U/L * Creatinine clearance greater than 60 mL/min * Normal electrocardiogram * No recent history of cardiac ischemia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Hepatitis B negative * No evidence of clinical immunodeficiency syndromes or immunodeficiency associated diseases * No history of autoimmune disease * No concurrent major illness * No serious infection requiring intravenous antibiotics * No active peptic ulcer disease * Must have free flow of fluid into the peritoneal space * No leakage from the catheter exit site PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2) * No prior recombinant human interleukin-12 * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No concurrent systemic chemotherapy * No concurrent systemic corticosteroids * No prior radiation therapy to the whole abdomen * No concurrent radiotherapy * At least 3 weeks since prior exposure to any investigational drug * No concurrent investigational drug
References
Publications (0)
Data not yet available
No reference posted for this study.