Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melano… (NCT00003789) | Clinical Trial Compass
CompletedPhase 3
Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
United States216 participantsStarted 1999-03
Plain-language summary
Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating melphalan to several degrees above body temperature and infusing it only to the area around the tumor may kill more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor is more effective than melphalan alone in treating melanoma.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Histologically proven locally advanced melanoma of an extremity
* One or more evaluable in-transit metastases
* All disease within the perfusion field of the extremity (with no local resection options short of amputation)
* Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true:
* High tumor burden (more than 10 lesions or any single lesion greater than 3 cm)
* Presence of pain, edema, skin breakdown, or decreased mobility
* Greater than 80% of known tumor is within extremity perfusion field
* Life expectancy more than 6 months
* No brain metastases
* At least 1 bidimensionally measurable lesion
* Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following:
* Disease-free interval for at least 6 months after prior ILP with melphalan
* Disease-free interval for at least 3 months after prior ILP with an agent other than melphalan
* Patients who received prior therapeutic ILP must have 1 of the following:
* Partial response of at least 3 months duration after prior ILP with melphalan
* Stable response or disease progression after ILP without melphalan (performed at least 3 months prior to study)
* Performance status - ECOG 0-2
* Performance status - Zubrod 0-2
* See Disease Characteristics
* Platelet count at least 100,000/mm\^3
* WBC greater than 2,500/mm\^3
* Hemoglobin greater than 9 g/dL
* Bilirubin less than 1.2…
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
CR proportion
Timeframe: Up to 3 months after completion of study treatment
2
Incidence of adverse events, graded according to NCI CTC version 2.0
Timeframe: Up to 1 month after completion of study treatment