Interleukin-12 in Treating Patients With Cancer in the Abdomen

Phase 1

Completed

• Conditions: Colorectal Cancer; Gallbladder Cancer; Pancreatic Cancer; Anal Cancer; Gastric Cancer
• Interventions: Biological: Recombinant Interleukin-12

• Registration Number: NCT00003046
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study Start: 1997-08
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted QC: 2004-02-18
• Study First Posted: 2004-02-19
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interleukin-12	Recombinant Interleukin-12	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12	4 weeks	MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States