- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019786
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate
|
Overall survival
|
Duration of response
|
Disease-free survival
|
Patterns of recurrence
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- liver metastases
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- localized unresectable adult primary liver cancer
- adult primary hepatocellular carcinoma
- stage IV childhood liver cancer
- recurrent childhood liver cancer
- recurrent islet cell carcinoma
- childhood hepatocellular carcinoma
- stage III childhood liver cancer
- neuroendocrine carcinoma
- adult primary cholangiocellular carcinoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Liver Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Neuroendocrine Tumors
- Adenoma
- Pancreatic Neoplasms
- Carcinoma
- Liver Neoplasms
- Carcinoma, Neuroendocrine
- Adenoma, Islet Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
Other Study ID Numbers
- 990123
- 99-C-0123
- CDR0000067220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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