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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019786
  Purpose

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 Intervention Phase
Colorectal Cancer
Islet Cell Tumor
Liver Cancer
Metastatic Cancer
Neuroendocrine Carcinoma
Drug: melphalan
Procedure: conventional surgery
Procedure: isolated perfusion
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer    Liver Cancer   

Drug Information available for:   Melphalan    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Patterns of recurrence [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:   67
Study Start Date:   August 1999

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019786

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     H. Richard Alexander, MD, FACS     NCI - Surgery Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067220, NCI-99-C-0123
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019786
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Melphalan
Liver Diseases
Carcinoma, Neuroendocrine
Carcinoma, Hepatocellular
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Liver neoplasms
Rectal Diseases
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Rectal cancer
Hepatocellular carcinoma
Endocrine Gland Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Carcinoma, Islet Cell
Endocrine System Diseases
Adenoma, Islet Cell
Intestinal Diseases
Recurrence
Intestinal Neoplasms
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Digestive System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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