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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
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted15 to 80NCISWOG-8593
CAN-NCIC-ME6, CLB-8795, EORTC-18832, EST-2686, INT-0065, ME6

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


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


Patient Characteristics:


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


Expected Enrollment

175 patients per treatment arm will be required; it is anticipated that 
accrual will continue for another 3 years.

Outline

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.

Published Results

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.

Related Publications

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

Edward Krementz, MD, Protocol chair (Contact information may not be current)
Ph: 504-488-5415; 800-588-5300

Eastern Cooperative Oncology Group

Thomas Smith, MD, Protocol chair
Ph: 425-339-5442
Email: tsmith@everettclinic.com

European Organization for Research and Treatment of Cancer

Maurizio Vaglini, MD, Protocol chair
Ph: 39-02-239-0761

NCIC-Clinical Trials Group

Joseph Pater, MD, Protocol chair
Ph: 613-533-6430
Email: jpater@ctg.queensu.ca

Cancer and Leukemia Group B

Michail Shafir, MD, Protocol chair
Ph: 212-241-0853
Email: michail.shafir@msnyuhealth.org

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.

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