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

NCT ID: NCT00265863

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Metastatic Cancer

Keywords

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malignant ascites

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Malignant Ascites

Patients meeting protocol criteria enrolled with malignant ascites.

Group Type EXPERIMENTAL

mitomycin C

Intervention Type DRUG

Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Interventions

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mitomycin C

Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.

Intervention Type DRUG

Other Intervention Names

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MTC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Masonic Cancer Center, University of Minnesota

Principal Investigators

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Todd M. Tuttle, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Locations

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University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2004LS043

Identifier Type: -

Identifier Source: org_study_id