Back to resultsMitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Primary Purpose
Metastatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mitomycin C
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring malignant ascites
Eligibility Criteria
Inclusion Criteria: Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan Not eligible for cytoreductive surgery based on any of the following criteria: Metastases outside peritoneal cavity Poor performance status Unresectable peritoneal disease Must have undergone at least 1 prior paracentesis procedure No ascites caused by any of the following conditions: Cardiac failure Nephrotic syndrome Pancreatic ascites Chylous ascites Eastern Cooperative Oncology Group (ECOG) performance status 0-3 WBC ≥ 3,000/mm^3 Platelet count ≥ 70,000/mm^3 Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 1.5 mg/dL Not pregnant or nursing Negative pregnancy test Exclusion Criteria: Prior peritoneal chemotherapy Dense intraabdominal adhesions limiting laparoscopy
Sites / Locations
- University of Minnesota Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Malignant Ascites
Arm Description
Patients meeting protocol criteria enrolled with malignant ascites.
Outcomes
Primary Outcome Measures
Prevention of malignant recurrence
Secondary Outcome Measures
Quality of life after treatment
Comparison of serum vascular endothelial growth factor (VEGF) levels
Full Information
NCT ID
NCT00265863
First Posted
December 14, 2005
Last Updated
November 27, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00265863
Brief Title
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Official Title
Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to slow accrual
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
malignant ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Malignant Ascites
Arm Type
Experimental
Arm Description
Patients meeting protocol criteria enrolled with malignant ascites.
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Other Intervention Name(s)
MTC
Intervention Description
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Primary Outcome Measure Information:
Title
Prevention of malignant recurrence
Time Frame
Week 4 after treatment
Secondary Outcome Measure Information:
Title
Quality of life after treatment
Time Frame
Week 4 after treatment
Title
Comparison of serum vascular endothelial growth factor (VEGF) levels
Time Frame
Pretreatment and Week 4 after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan
Not eligible for cytoreductive surgery based on any of the following criteria:
Metastases outside peritoneal cavity
Poor performance status
Unresectable peritoneal disease
Must have undergone at least 1 prior paracentesis procedure
No ascites caused by any of the following conditions:
Cardiac failure
Nephrotic syndrome
Pancreatic ascites
Chylous ascites
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
WBC ≥ 3,000/mm^3
Platelet count ≥ 70,000/mm^3
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Exclusion Criteria:
Prior peritoneal chemotherapy
Dense intraabdominal adhesions limiting laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M. Tuttle, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
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