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

Primary Purpose

Colorectal Cancer, Islet Cell Tumor, Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
isolated perfusion
melphalan
conventional surgery
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Response rate
Duration of response
Patterns of recurrence
Disease-free survival
Overall survival

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
March 21, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019786
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Islet Cell Tumor, Liver Cancer, Metastatic Cancer, Neuroendocrine Carcinoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
isolated perfusion
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Response rate
Title
Duration of response
Title
Patterns of recurrence
Title
Disease-free survival
Title
Overall survival

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Richard Alexander, MD, FACS
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14673042
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. doi: 10.1200/JCO.2003.04.150.
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Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

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