Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With… (NCT00324727) | Clinical Trial Compass
CompletedPhase 3
Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
United States93 participantsStarted 2006-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma.
PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma.
Who can participate
Age range
18 Years – 120 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 liver metastases secondary to cutaneous or ocular melanoma
* Unresectable disease
* Predominantly in the parenchyma of the liver
* Measurable disease by CT scan and/or MRI
* Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following:
* Up to 4 pulmonary nodules, each \< 1 cm in diameter
* Retroperitoneal lymph nodes \< 3 cm in diameter
* Less than 10 skin or subcutaneous metastases \< 1 cm in diameter
* Asymptomatic bone metastases that are eligible for or have undergone palliative external-beam radiotherapy
* Solitary metastasis to any site that can be resected
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 3 months
* ECOG performance status 0-2
* Bilirubin \< 3.0 mg/dL
* PT within 2 seconds of upper limit of normal (ULN)
* AST/ALT ≤ 10 times ULN
* Platelet count \> 75,000/mm\^3
* Hematocrit \> 27% (may be achieved with a transfusion)
* Absolute neutrophil count ≥ 1,300/mm\^3
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min
* Fertile patients must use effective contraception
* Not pregnant or nursing
* Negative pregnancy test
* No history of congestive heart failure
* LVEF ≥ 40%
* No significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease
* FEV\_1 ≥ 30%
* DLCO ≥ 40% of predicted
* Weight ≥ 35 kg
* No untreated ac…
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.