A Phase 2 interventional study of mitomycin C in Metastatic Cancer, sponsored by Masonic Cancer Center, University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment
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.
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.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 1 is below the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Not eligible for cytoreductive surgery based on any of the following criteria:
No ascites caused by any of the following conditions:
Exclusion Criteria:
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.
Also known as: 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
This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota