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

November 27, 2017 updated by: Masonic Cancer Center, University of Minnesota

Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • MTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevention of malignant recurrence
Time Frame: Week 4 after treatment
Week 4 after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life after treatment
Time Frame: Week 4 after treatment
Week 4 after treatment
Comparison of serum vascular endothelial growth factor (VEGF) levels
Time Frame: Pretreatment and Week 4 after treatment
Pretreatment and Week 4 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Study Chair: Todd M. Tuttle, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004LS043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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