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| Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003789 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: recombinant tumor necrosis factor family protein Drug: isolated limb perfusion Drug: melphalan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion and Melphalan With and Without Tumor Necrosis Factor in Patients With Localized Advanced Extremity Melanoma |
| Study Start Date: | March 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor burden (high vs low), prior reperfusion (melphalan vs other), regional nodal site (yes vs no), and participating center. Patients are randomized to one of two treatment arms.
Patients undergo perfusions of the upper extremity by the axillary artery and vein using an infraclavicular/axillary incision. Melphalan is introduced into the perfusion by slow injection over 5 minutes and allowed to remain for a total of 60 minutes.
PROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven locally advanced melanoma of an extremity
Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true:
Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following:
Patients who received prior therapeutic ILP must have 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201 | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| Abramson Cancer Center at University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Study Chair: | Douglas L. Fraker, MD | University of Pennsylvania |
More Information
| Study ID Numbers: | CDR0000066929, ACOSOG-Z0020, NCI-03-C-0137 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003789 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III melanoma recurrent melanoma |
|
Melphalan Immunologic Factors Immunosuppressive Agents Recurrence Melanoma Neuroendocrine Tumors Fever Neuroectodermal Tumors |
Necrosis Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Alkylating Agents |
|
Melphalan Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |