Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030082

Purpose

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	Intervention	Phase
Liver Cancer Metastatic Cancer	Drug: isolated perfusion Drug: melphalan	Phase I

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

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

Study Start Date:

July 2001

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030082

Locations

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

Study Chair:

H. Richard Alexander, MD, FACS

NCI - Surgery Branch

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068941, NCI-01-C-0215
Study First Received:	January 30, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00030082 History of Changes
Health Authority:	United States: Federal Government

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:

Melphalan
Liver Diseases
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Liver Neoplasms

Neoplasms
Neoplastic Processes
Neoplasms by Site
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009