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Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Start Date
August 1, 1997
Primary Completion Date
October 1, 2001
Completion Date
October 1, 2001
Last Updated
July 30, 2012
29
ACTUAL participants
Recombinant Interleukin-12
BIOLOGICAL
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
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