Expired Study
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Bethesda, Maryland 20892


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.


Study summary:

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.


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


Study is Available At:


Original ID:

990123


NCT ID:

NCT00019786


Secondary ID:

99-C-0123


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

67


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:H. Richard Alexander, MD, FACS
Study Chair
NCI - Surgery Branch

Study Dates

Start Date:August 1999
Completion Date:January 2006
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 21, 2012
First Received Date:July 11, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Overall survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Disease-free survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Patterns of recurrence
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Duration of response
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Response rate
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:isolated perfusion
Intervention Type:Drug
Name:melphalan
Intervention Type:Procedure
Name:conventional surgery

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institutes of Health Clinical Center (CC)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:14673042

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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