Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
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|ClinicalTrials.gov Identifier: NCT00265863|
Recruitment Status : Terminated (Withdrawn due to slow accrual)
First Posted : December 15, 2005
Last Update Posted : November 29, 2017
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 or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: mitomycin C||Phase 2|
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
Experimental: Patients with Malignant Ascites
Patients meeting protocol criteria enrolled with malignant ascites.
Drug: mitomycin C
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Other Name: MTC
- Prevention of malignant recurrence [ Time Frame: Week 4 after treatment ]
- Quality of life after treatment [ Time Frame: Week 4 after treatment ]
- Comparison of serum vascular endothelial growth factor (VEGF) levels [ Time Frame: Pretreatment and Week 4 after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265863
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Todd M. Tuttle, MD||Masonic Cancer Center, University of Minnesota|