Clinical trial · Interventional
Interleukin-12 in Treating Patients With Cancer in the Abdomen
Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas
- 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: Interleukin-12 may kill tumor cells by stimulating a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with cancer in the abdomen.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interleukin-12
- interventionNames
- Biological: Recombinant Interleukin-12
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12
- timeFrame
- 4 weeks
- description
- MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Mullerian carcinoma (ovarian epithelial or peritoneal carcinoma) (closed to accrual as of 8/23/01) OR Gastrointestinal cancer with abdominal carcinomatosis OR Peritoneal mesothelioma (closed to accrual as of 8/23/01) Must have received an adequate course of any platinum-based chemotherapy regimen for ovarian cancer with evidence of intraabdominal disease Must have received an adequate course of fluorouracil-based treatment for metastatic colon cancer Intact primary gastrointestinal tumor allowed if not at risk of obstruction and/or bleeding Abdominal lesions must be less than 10 cm Extraperitoneal lesions must be less than 2 cm No hepatic disease No clinically significant pleural effusion (controlled by pleurodesis allowed) No brain metastases No significant adhesions or symptoms of obstruction PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Lymphocyte count at least 800/mm3 Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL SGOT or SGPT less than 2.5 times upper limit of normal Albumin at least 3.5 g/dL Hepatitis B and C negative Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Loss of no more than 10% of body weight over a 4 month period No overt autoimmune disease No active ulcer disease No prior inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No concurrent chemotherapy Endocrine therapy: No chronic steroid therapy Radiotherapy: At least 3 months since prior localized radiotherapy (e.g., pelvic or small field) and recovered No radiotherapy to whole abdomen No concurrent radiotherapy Surgery: Recovered from prior surgery At least 3 weeks since prior major abdominal surgery At least 2 weeks since prior laparoscopy
References
Publications (1)
- RESULTLenzi R, Kudelka AP, Veschraegen C, et al.: Intraperitoneal (IP) bioimmunologic responses in patients with ovarian and gastrointestinal cancers at a low toxicity dosing schedule of IP recombinant interleukin-12 (rhIL-12). [Abstract] Proc Am Assoc Cancer Res 40: A3778, 573, 1999.