NCT00265863

Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells. PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.

Detailed description

OBJECTIVES: Primary * Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites. Secondary * Determine any improvement in the quality of life of patients treated with this procedure. OUTLINE: This is a nonrandomized study. Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes. Quality of life is assessed at study entry and at 4 weeks. After completion of study treatment, patients are followed periodically for 2 years.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	mitomycin C	Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2005-12-15
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States