Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic, Treatment	Closed	18 to 75	Other	RPCI-DS-94-24 NCI-V97-1194

Objectives

I.  Determine whether wide excision of the primary with intraoperative 
lymphatic mapping followed by selective lymphadenectomy will effectively 
prolong overall survival compared to wide excision of the primary melanoma 
alone.

Entry Criteria

Disease Characteristics:

Stage I or II cutaneous melanoma (except primary melanoma of mucous
membranes, eyes or ears) with:

  Clark level III and Breslow thickness at least 1.00 mm OR
  Clark level IV or V with any Breslow thickness

No evidence of satellite or intransit lesions

No evidence of regional nodal or distant metastases

No second primary invasive melanoma

Prior/Concurrent Therapy:

Biologic therapy:
 No prior immunotherapy

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy

Surgery:
 No prior wide excision of primary melanoma with a longitudinal diameter of 3  
    cm or less or lateral margin of 1.5 cm or less
 No prior skin grafts, tissue transfers or flaps
 No prior lymph node dissection that may alter lymphatic drainage from a       
   primary site to the adjacent regional lymph node basins

Other:
 No oral or parenteral steroids within the past 6 months
 No immunosuppressive drugs within the past 6 months
 

Patient Characteristics:

Age:
 18 to 75

Performance status:
 Not specified

Life expectancy:
 At least 10 years from diagnosis (excluding potential effect of melanoma)

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No previous malignancy other than squamous or basal cell carcinoma or         
   carcinoma in situ of the cervix
 No prior autoimmune disease or transplantation
 Not pregnant

Expected Enrollment

Approximately 1,050 patients will be accrued nationally over 8 years: 900 will
 be accrued into the Breslow thickness 1.2-3.5 mm group, and 150 will be       
  accrued into the other groups.

Outline

This is a multicenter randomized study.  Patients are stratified according to 
primary site (extremity vs nonextremity) and Breslow thickness.  Patients are 
randomized to receive either wide local excision of primary melanoma or wide 
local excision with intraoperative lymphatic mapping and selective 
lymphadenectomy.

Patients who receive intraoperative lymphatic mapping have isosulfan blue dye 
injected intradermally near the lesion.  The dye is carried by the lymphatics 
to the first (sentinel) node to which these lymphatics are afferent vessels.  
The regional nodal basin is then exposed and the sentinel node is identified 
by the dye.  If a biopsy reveals that the sentinel node is positive for 
melanoma, a complete lymphadenectomy is performed. 

Patients are given follow up exams every 3 months for the first two years, 
every 4 months for the third year, every 6 months for the fourth and fifth 
years and yearly thereafter.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

William Kraybill, MD, FACS, Protocol chair		Ph: 716-845-3284; 800-685-6825 Email: william.kraybill@roswellpark.org