Interleukin-12 in Treating Patients With Cancer in the Abdomen
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|ClinicalTrials.gov Identifier: NCT00003046|
Recruitment Status : Completed
First Posted : February 19, 2004
Last Update Posted : July 30, 2012
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 or disease||Intervention/treatment||Phase|
|Anal Cancer Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer||Biological: Recombinant Interleukin-12||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas|
|Study Start Date :||August 1997|
|Primary Completion Date :||October 2001|
|Study Completion Date :||October 2001|
Biological: Recombinant Interleukin-12
Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses
- Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12 [ Time Frame: 4 weeks ]MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003046
|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|