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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00265863 |
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.
Condition | Intervention | Phase |
Metastatic Cancer |
Drug: mitomycin C Procedure: hyperthermia treatment Procedure: laparoscopic surgery |
Phase II |
MedlinePlus related topics: | Cancer Fever |
ChemIDplus related topics: | Mitomycin Mitomycins |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Not eligible for cytoreductive surgery based on any of the following criteria:
No ascites caused by any of the following conditions:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
United States, Minnesota | |||||
University of Minnesota Cancer Center | |||||
Minneapolis, Minnesota, United States, 55455 |
Masonic Cancer Center, University of Minnesota |
National Cancer Institute (NCI) |
Study Chair: | Todd M. Tuttle, MD | Masonic Cancer Center, University of Minnesota |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000450848, UMN-2004LS043 |
First Received: | December 14, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00265863 |
Health Authority: | United States: Federal Government |
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