Phase III Randomized Adjuvant Local Perfusion with L-PAM plus Local Hyperthermia Followed by Surgical Excision vs Surgery Alone in Patients with High-Risk Stage I Malignant Melanoma of the Extremities
Basic Trial Information
|Phase III||Treatment||Completed||15 to 80||NCI||SWOG-8593|
CAN-NCIC-ME6, CLB-8795, EORTC-18832, EST-2686, INT-0065, ME6
I. Evaluate the efficacy of iliac or axillary prophylactic isolation perfusion with melphalan under controlled hyperthermia following wide excision with or without elective lymph node dissection compared to surgery alone in patients with high-risk Stage I malignant melanoma of the extremities. II. Compare the disease-free interval, survival from surgery, and toxicity/morbidity in the two treatment groups.
Histologically verified, Stage I malignant melanoma of the skin located at or distal to the middle of the thigh or arm Melanoma of the digits acceptable Lesion more than 1.5 mm in maximum thickness (Breslow) The following histologies are eligible: Superficial spreading melanoma Nodular melanoma Acral lentiginous melanoma Unclassified melanoma No lentigo malignant melanoma of the extremities No evidence of regional or distant metastases on physical examination and laboratory workup
Biologic therapy: No prior systemic immunotherapy for melanoma Chemotherapy: No prior chemotherapy for melanoma for melanoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for melanoma Surgery: No more than 6 weeks since excision biopsy or ray excision No prior regional lymph node dissection or biopsy No more than 3-cm margins around the primary
Age: 15-80 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Dorsalis or posterior tibial arteries palpable No symptoms of vascular insufficiency Older patients with possible atherosclerosis should have an arteriogram or a noninvasive Doppler study prior to entry Other: No prior malignancy except: Basal cell skin carcinoma In situ carcinoma of the cervix
175 patients per treatment arm will be required; it is anticipated that accrual will continue for another 3 years.
Randomized study. Arm I: Surgery. Wide excision with or without elective lymph node dissection. The decision as to whether or not lymph node dissection is performed is to be made at each institution as per institutional policy. Arm II: Single-Agent Local Perfusion Chemotherapy plus Hyperthermia followed by Surgery. Melphalan, L-PAM, NSC-8806; plus Hyperthermia; followed by Surgery as in Arm I.
Koops HS, Vaglini M, Suciu S, et al.: Prophylactic isolated limb perfusion for localized, high-risk limb melanoma: results of a multicenter randomized phase III trial. European Organization for Research and Treatment of Cancer Malignant Melanoma Cooperative Group Protocol 18832, the World Health Organization Melanoma Program Trial 15, and the North American Perfusion Group Southwest Oncology Group-8593. J Clin Oncol 16 (9): 2906-12, 1998.[PUBMED Abstract]
Lejeune F, Lienard D, Koops H, et al.: Treatment of in-transit melanoma metastases with tumor necrosis factor (TNF-a) and chemotherapy administrered in isolated limb perfusion (ILP). [Abstract] Proceedings of the 4th World Conference on Melanoma 7(suppl 1): A167, 848, 1997.
Joosse A, Collette S, Suciu S, et al.: Superior outcome of women with stage I/II cutaneous melanoma: pooled analysis of four European Organisation for Research and Treatment of Cancer phase III trials. J Clin Oncol 30 (18): 2240-7, 2012.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
Ph: 504-488-5415; 800-588-5300
Eastern Cooperative Oncology Group
European Organization for Research and Treatment of Cancer
NCIC-Clinical Trials Group
Cancer and Leukemia Group B
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.