Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| isolated perfusion | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Response rate
- measure
- Duration of response
- measure
- Patterns of recurrence
- measure
- Disease-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 therapyReferences
Publications (1)
- RESULTFeldman 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. PMID 14673042