NCT00003046

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anal Cancer
• Colorectal Cancer
• Gallbladder Cancer
• Gastric Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Interleukin-12	Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses

Timeline

• Start date: 1997-08-01
• Primary completion: 2001-10-01
• Completion: 2001-10-01
• First posted: 2004-02-19
• Last updated: 2012-07-30

Locations

1 site across 1 country: United States