Clinical trial · Interventional
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
A Phase II Study Of Hepatic Arterial Infusion Of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) For Unresectable Primary And Metastatic 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: 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 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 giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| isolated perfusion | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Melphalan Administration PHP
- interventionNames
- Drug: isolated perfusion
- Drug: melphalan
Primary outcomes (1)
- measure
- To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies
- timeFrame
- Survivial
Secondary outcomes (2)
- measure
- To determine the patterns of recurrence following percutaneous hepatic perfusions (PHP) with melphalan
- timeFrame
- Survival
- measure
- To determine the progression free and overall survival in patients with hepatic malignancies following this therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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 therapyReferences
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