Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
NCT ID: NCT00019786
Last Updated: 2012-03-23
Study Results
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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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
1999-08-31
2006-01-31
Brief Summary
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PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.
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Detailed Description
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* Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
* Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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isolated perfusion
melphalan
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Congestive heart failure allowed if LVEF ≥ 40%
Pulmonary:
* No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age
Other:
* Weight greater than 30 kg
* Not pregnant or nursing
* Negative pregnancy test
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 month since prior anticancer biologic therapy and recovered
Chemotherapy:
* At least 1 month since prior anticancer chemotherapy and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 1 month since prior anticancer radiotherapy and recovered
Surgery:
* Not specified
Other:
* Prior intrahepatic arterial infusion therapy allowed
* No chronic use of anticoagulants
* No concurrent immunosuppressive therapy
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health Clinical Center (CC)
NIH
Principal Investigators
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H. Richard Alexander, MD, FACS
Role: STUDY_CHAIR
NCI - Surgery Branch
Locations
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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Countries
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References
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Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7. doi: 10.1200/JCO.2003.04.150.
Other Identifiers
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99-C-0123
Identifier Type: -
Identifier Source: secondary_id
CDR0000067220
Identifier Type: -
Identifier Source: secondary_id
990123
Identifier Type: -
Identifier Source: org_study_id
NCT00001820
Identifier Type: -
Identifier Source: nct_alias
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