Clinical trial · Interventional
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma
- 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 II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (recombinant interleukin-12)
- description
- Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses.
- interventionNames
- Biological: recombinant interleukin-12
Primary outcomes (3)
- measure
- Rate of remission determined by laparoscopy or laparotomy
- timeFrame
- Up to 2 years
- description
- Tested using an exact test for a single binomial proportion
- measure
- Toxicity graded using the NCI CTC version 3.0
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma * Surgically documented disease after prior platinum-based chemotherapy with or without surgery * Minimal residual disease, defined as metastases less than 1 cm in largest diameter * No significant adhesions or symptoms of obstruction * No extra-abdominal or parenchymal disease * No more than 6 weeks since prior primary chemotherapy * Performance status - Zubrod 0-1 * Absolute granulocyte count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Lymphocyte count greater than 600/mm\^3 * Bilirubin no greater than 1.5 mg/dL * SGOT or SGPT no greater than 2.5 times upper limit of normal * Albumin at least 3.0 g/dL * Hepatitis B and C negative * Creatinine no greater than 1.5 mg/dL * No significant cardiac disease * No significant pulmonary disease * No overt autoimmune disease * No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer * HIV negative * Successful placement of peritoneal catheter * No prior immunotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No concurrent chemotherapy * No chronic steroid therapy * No prior radiotherapy * See Disease Characteristics * Recovered from prior surgery * At least 2 weeks since prior laparoscopy * At least 4 weeks since prior laparotomy
References
Publications (0)
Data not yet available