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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Recruitment Status : Terminated (Withdrawn due to slow accrual)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
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: mitomycin C Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
Study Start Date : August 2004
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Mitomycin
U.S. FDA Resources

Arms and Interventions

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 Name: MTC


Outcome Measures

Primary Outcome Measures :
  1. Prevention of malignant recurrence [ Time Frame: Week 4 after treatment ]

Secondary Outcome Measures :
  1. Quality of life after treatment [ Time Frame: Week 4 after treatment ]
  2. Comparison of serum vascular endothelial growth factor (VEGF) levels [ Time Frame: Pretreatment and Week 4 after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Todd M. Tuttle, MD Masonic Cancer Center, University of Minnesota
More Information

Responsible Party: Todd Tuttle, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00265863     History of Changes
Other Study ID Numbers: 2004LS043
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
malignant ascites

Additional relevant MeSH terms:
Neoplasm Metastasis
Ascites
Fever
Neoplastic Processes
Neoplasms
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors