CompletedPhase 2

Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer

United States56 participantsStarted 2004-09

Plain-language 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 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.

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Hematopoie…

What they're measuring

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

Trial details

NCT IDNCT00096083

SponsorDelcath Systems Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08