Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12
MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.
4 weeks
Yes
Renato Lenzi, MD
Study Chair
M.D. Anderson Cancer Center
United States: Institutional Review Board
ID97-027
NCT00003046
August 1997
October 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |