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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003046 |
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.
Condition | Intervention | Phase |
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Anal Cancer Carcinoma of the Appendix Colorectal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Malignant Mesothelioma Pancreatic Cancer Small Intestine Cancer |
Drug: recombinant interleukin-12 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas |
Estimated Enrollment: | 40 |
Study Start Date: | August 1997 |
OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal interleukin-12 in patients with Mullerian carcinoma (closed to accrual as of 8/23/01), gastrointestinal carcinoma, or peritoneal mesothelioma (closed to accrual as of 8/23/01). II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive intraperitoneal interleukin-12 over 30 minutes once weekly for 4 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responsive disease may receive an additional 6 courses. Patients receive escalating doses of intraperitoneal interleukin-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to receive interleukin-12 at the recommended dose.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Renato Lenzi, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000065681, MDA-ID-97027, NCI-T97-0034 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003046 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV gastric cancer recurrent gastric cancer recurrent pancreatic cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer stage IV anal cancer recurrent anal cancer metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor |
advanced malignant mesothelioma recurrent malignant mesothelioma small intestine adenocarcinoma unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer recurrent small intestine cancer carcinoma of the appendix stage IV pancreatic cancer |
Gallbladder Diseases Rectal Neoplasms Pancreatic Neoplasms Colonic Diseases Rectal Diseases Ileal Diseases Duodenal Neoplasms Neuroepithelioma Rectal cancer Endocrine Gland Neoplasms Digestive System Neoplasms Endocrine System Diseases Stomach cancer Malignant Carcinoid Syndrome Carcinoma |
Gall bladder cancer Neuroectodermal Tumors Bile Duct Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Bile Duct Neoplasms Gallbladder Neoplasms Colonic Neoplasms Anus Neoplasms Neoplasms, Glandular and Epithelial Interleukin-12 Gastrointestinal Diseases Stomach Diseases Ileal Neoplasms |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Neoplasms, Mesothelial Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Jejunal Diseases Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Anus Diseases |