Status:
COMPLETED
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
Lead Sponsor:
Delcath Systems Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells...
Detailed Description
OBJECTIVES: Primary * Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan w...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed hepatic malignancy
- Unresectable disease
- Disease predominantly in the parenchyma of the liver
- One of the following primary tumor histologies:
- Adenocarcinoma of gastrointestinal or other origin
- Neuroendocrine tumor (except gastrinoma)
- Primary hepatic malignancy (e.g., hepatocellular cancer or intra-hepatic cholangiocarcinoma)
- Cutaneous or ocular melanoma (patients must have received prior regional melphalan therapy)
- Hepatic metastases from colorectal tumors allowed provided patient has undergone prior first-line chemotherapy, including irinotecan or oxaliplatin
- Limited unresectable extrahepatic disease on preoperative radiological studies allowed if life-limiting component of progressive disease is in the liver
- Limited extrahepatic disease includes, but is not limited to, the following:
- Up to 4 pulmonary nodules each \< 1 cm in diameter
- Retroperitoneal lymph nodes each \< 3 cm in diameter
- Less than 10 skin or subcutaneous metastases each \< 1 cm in diameter
- Asymptomatic bone metastases that have been or could be palliatively treated with external beam radiotherapy
- Resectable solitary metastasis to any site
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 16 and over
- Sex
- Male or Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Platelet count ≥ 75,000/mm\^3
- Hematocrit \> 27%
- Absolute neutrophil count ≥ 1,300/mm\^3
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- PT ≤ 2 seconds of upper limit of normal (ULN)
- AST and ALT ≤ 10 times ULN
- No Childs class B or C cirrhosis
- No portal hypertension by history, endoscopy, or radiologic studies
- Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance \> 60 mL/min
- Cardiovascular
- No congestive heart failure
- LVEF ≥ 40%
- Pulmonary
- No chronic obstructive pulmonary disease
- FEV\_1 ≥ 30% of predicted
- DLCO ≥ 40% of predicted
- Immunologic
- No active infection
- No severe allergic reaction to iodine contrast agent that is not controlled by premedication with antihistamines or steroids
- No known hypersensitivity reaction to melphalan or heparin in the presence of a heparin induced thrombocytopenia (HIT) antibody
- Other
- Weight \> 35 kg
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No documented latex allergy
- No evidence of intracranial abnormalities which would lead to risk for bleeding with anticoagulation (e.g., stroke or active metastasis)
- No evidence of active ulcer disease
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 1 month since prior biologic therapy and recovered
- Chemotherapy
- See Disease Characteristics
- More than 1 month since prior chemotherapy and recovered
- Endocrine therapy
- Premenopausal women (i.e., have had a period within the past 12 months) must be willing to undergo hormonal suppression during study treatment
- Radiotherapy
- See Disease Characteristics
- More than 1 month since prior radiotherapy and recovered
- Surgery
- No prior Whipple resection
- Other
- Prior intrahepatic perfusion (with or without arterial infusion with floxuridine) or peripheral hepatic perfusion allowed provided the patient had a radiographic partial response of 3 months' duration after therapy
- No concurrent immunosuppressive drugs
- No concurrent chronic anticoagulation therapy
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00096083
Start Date
September 1 2004
End Date
August 1 2012
Last Update
October 23 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182