A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necros… (NCT00001296) | Clinical Trial Compass
CompletedPhase 3
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma
United States122 participantsStarted 1992-02
Plain-language summary
Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.
Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.
Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.
Who can participate
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:
Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:
Advanced local disease indicated by 2 or more satellite or in-transit metastases.
Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.
Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.
No evidence of systemic disease outside the involved extremity.
Recurrent disease subsequent to prior successful limb perfusion allowed.
Bidimensional directly measurable dermal or subcutaneous lesion required.
PRIOR/CONCURRENT THERAPY:
No prior isolated limb perfusion.
Biologic Therapy: At least 1 month since Biologic Therapy.
At least 3 months since regional therapy of the extremity.
Chemotherapy: At least 1 month since chemotherap.y
At least 3 months since regional therapy of the extremity.
Endocrine Therapy: Not specified.
Radiotherapy: At least 1 month since radiotherapy.
Surgery: Not specified.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0 or 1.
Hematopoietic: Platelets greater than 150,000.
Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.
Renal: Creatinine less than 2.0 mg/dl.
Cardiovascular: No evidence of peripheral vascular disease, e.g.:
No history of claudication.
OTHER:
HIV negative.
No pregnant or nursing women.
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.