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Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00030082
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.


Condition or disease Intervention/treatment Phase
Liver Cancer Metastatic Cancer Drug: isolated perfusion Drug: melphalan Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial infusion with melphalan in patients with unresectable liver cancer.
  • Determine the regional and systemic toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo percutaneous hepatic arterial infusion, using a double balloon catheter in the inferior vena cava to isolate circulation to the liver, with melphalan over 30 minutes on day 1. Treatment may be repeated when all toxic effects are grade 2 or less. Patients undergo staging at 4 weeks after completion of the second treatment. Patients may receive 2 additional treatments.

Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated with melphalan at the recommended dose.

Patients are followed every 3 months for 2 years and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan With Venous Filtration for Metastatic Unresectable Cancers of the Liver
Study Start Date : July 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer





Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed unresectable cancer of the parenchyma of the liver
  • Liver metastases allowed
  • Limited unresectable extrahepatic disease (including but not limited to the following) is allowed provided the life-threatening component of progressive disease is in liver:

    • Up to 4 pulmonary nodules each less than 1 cm in diameter
    • Retroperitoneal lymph nodes less than 3 cm in diameter
    • Fewer than 10 skin or subcutaneous metastases less than 1 cm in diameter
    • Asymptomatic bone metastases that have been or can be palliated with radiotherapy
    • Solitary metastasis to any site that can be resected
  • Prior therapy with intrahepatic perfusion with or without hepatic arterial infusion with floxuridine is allowed provided patient had a radiographic partial response of 3-months duration

PATIENT CHARACTERISTICS:

Age:

  • 14 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count greater than 100,000/mm^3
  • Absolute neutrophil count at least 1,300/mm^3
  • Hematocrit greater than 27%

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • PT within 2 seconds of upper limit of normal
  • No biopsy-proven cirrhosis with evidence of portal hypertension by history, endoscopy, or radiologic study

Renal:

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

Cardiovascular:

  • No prior congestive heart failure with LVEF less than 40%

Pulmonary:

  • No chronic obstructive pulmonary disease
  • No other chronic pulmonary disease
  • FEV_1 at least 30% of predicted
  • DLCO at least 40% of predicted

Other:

  • Weight greater than 35 kg
  • HIV negative
  • No active infections
  • No severe allergic reaction to iodine contrast not controlled by antihistamines or steroids
  • No known prior hypersensitivity reaction to melphalan
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 month since prior biologic therapy for the malignancy and recovered

Chemotherapy:

  • See Disease Characteristics
  • At least 1 month since prior chemotherapy for the malignancy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 1 month since prior radiotherapy for the malignancy and recovered

Surgery:

  • Not specified

Other:

  • No concurrent chronic anticoagulants
  • No concurrent immunosuppressive drugs

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): NCT00030082


Locations
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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 Cancer Institute (NCI)
Investigators
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Study Chair: H. Richard Alexander, MD, FACS NCI - Surgery Branch

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ClinicalTrials.gov Identifier: NCT00030082    
Obsolete Identifiers: NCT00021606
Other Study ID Numbers: CDR0000068941
NCI-01-C-0215
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: July 2004
Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
liver metastases
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs