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Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019786
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 23, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Islet Cell Tumor Liver Cancer Metastatic Cancer Neuroendocrine Carcinoma Drug: isolated perfusion Drug: melphalan Procedure: conventional surgery Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
Study Start Date : August 1999
Actual Study Completion Date : January 2006

Primary Outcome Measures :
  1. Response rate
  2. Duration of response
  3. Patterns of recurrence
  4. Disease-free survival
  5. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically proven liver cancer meeting 1 of the following criteria:

    • Primary unresectable hepatocellular or cholangiocellular carcinoma
    • Metastatic cancer to the liver originating from one of the following:

      • Intraocular melanoma (closed to accrual as of 10/17/03)
      • Islet cell carcinoma
      • Adenocarcinoma of the colon or rectum limited to parenchyma of the liver

        • No evidence of other unresectable extrahepatic colorectal metastasis
    • Other neuroendocrine tumors, such as carcinoid tumors
  • Measurable disease



  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 27.0%
  • WBC at least 2,500/mm^3


  • Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
  • PT no greater than 2 seconds above upper limit of normal
  • Elevated SGOT and SGPT allowed if not due to hepatitis
  • No biopsy-proven cirrhosis or evidence of significant portal hypertension
  • No prior or concurrent veno-occlusive disease
  • Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • Congestive heart failure allowed if LVEF ≥ 40%


  • No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age


  • Weight greater than 30 kg
  • Not pregnant or nursing
  • Negative pregnancy test
  • No active infection


Biologic therapy:

  • At least 1 month since prior anticancer biologic therapy and recovered


  • At least 1 month since prior anticancer chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • At least 1 month since prior anticancer radiotherapy and recovered


  • Not specified


  • Prior intrahepatic arterial infusion therapy allowed
  • No chronic use of anticoagulants
  • No concurrent immunosuppressive therapy

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 identifier (NCT number): NCT00019786

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: H. Richard Alexander, MD, FACS NCI - Surgery Branch
Publications of Results:
Layout table for additonal information Identifier: NCT00019786    
Obsolete Identifiers: NCT00001820
Other Study ID Numbers: 990123
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent islet cell carcinoma
adult primary hepatocellular carcinoma
adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases
adult primary cholangiocellular carcinoma
advanced adult primary liver cancer
recurrent childhood liver cancer
childhood hepatocellular carcinoma
stage III childhood liver cancer
stage IV childhood liver cancer
neuroendocrine carcinoma
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Neuroendocrine
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs