Clinical trial · Interventional
Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer
A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan With Venous Filtration for Metastatic Unresectable Cancers of the Liver
NCT00030082CI-TRIAL-00017748completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| isolated perfusion | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable cancer of the parenchyma of the liver * Liver metastases allowed * Limited unresectable extrahepatic disease (including but not limited to the following) is allowed provided the life-threatening component of progressive disease is in liver: * Up to 4 pulmonary nodules each less than 1 cm in diameter * Retroperitoneal lymph nodes less than 3 cm in diameter * Fewer than 10 skin or subcutaneous metastases less than 1 cm in diameter * Asymptomatic bone metastases that have been or can be palliated with radiotherapy * Solitary metastasis to any site that can be resected * Prior therapy with intrahepatic perfusion with or without hepatic arterial infusion with floxuridine is allowed provided patient had a radiographic partial response of 3-months duration PATIENT CHARACTERISTICS: Age: * 14 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count at least 1,300/mm\^3 * Hematocrit greater than 27% Hepatic: * Bilirubin no greater than 2.0 mg/dL * PT within 2 seconds of upper limit of normal * No biopsy-proven cirrhosis with evidence of portal hypertension by history, endoscopy, or radiologic study Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No prior congestive heart failure with LVEF less than 40% Pulmonary: * No chronic obstructive pulmonary disease * No other chronic pulmonary disease * FEV\_1 at least 30% of predicted * DLCO at least 40% of predicted Other: * Weight greater than 35 kg * HIV negative * No active infections * No severe allergic reaction to iodine contrast not controlled by antihistamines or steroids * No known prior hypersensitivity reaction to melphalan * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior biologic therapy for the malignancy and recovered Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy for the malignancy and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 1 month since prior radiotherapy for the malignancy and recovered Surgery: * Not specified Other: * No concurrent chronic anticoagulants * No concurrent immunosuppressive drugs
References
Publications (0)
Data not yet available
No reference posted for this study.