Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresecta… (NCT00096083) | Clinical Trial Compass
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 range
16 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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