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

Alternate Title

Surgery With or Without Lymph Node Mapping and Removal in Treating Patients With Stage I or Stage II Melanoma

Basic Trial Information

Objectives

I.  Determine whether intraoperative lymphatic mapping followed by selective 
lymphadenectomy in addition to wide excision of the primary melanoma in 
patients with invasive cutaneous melanoma effectively prolongs disease-free 
survival and overall survival as compared to patients with wide excision of 
the primary melanoma alone.

II.  Assess whether intraoperative lymphatic mapping followed by selective 
lymphadenectomy can reduce the incidence, time to appearance, and anatomic 
distribution of distant metastases relative to patients managed by wide 
excision only.

III.  Assess the incidence of morbidity in these two treatment groups.

IV.  Determine whether tumor associated antigen (TAA-90) specific immune 
complexes are useful in predicting the presence of regional nodal or distant 
subclinical metastases in clinical Stage I melanoma.

V.  Compare the incidence of metastases detected in the sentinel nodes with 
the incidence of subsequent clinically detected metastases in patients treated 
by wide excision only.

VI.  Compare the rate of lymph node metastases after wide excision of the 
primary alone with the rate of lymph node metastases after excision of a 
microscopically negative sentinel node biopsy.

VII.  Evaluate the accuracy of lymphatic mapping and selective lymph node 
dissection in determining the presence of clinically occult regional nodal 
metastases.

Entry Criteria

Disease Characteristics:

Histologically confirmed Stage IB, IIA, or IIB (excluding satellite lesions)
primary invasive cutaneous melanoma that meet one of the following criteria:
 Clark Level III and Breslow thickness at least 1.00 mm OR
 Clark Level IV or V with any Breslow thickness 

Primary cutaneous melanoma site must be on the head, neck, trunk, extremity,
scalp, palm of the hand, sole of the foot, or subungual skin
 No primary cutaneous melanoma involving the eye, ear, or mucous membranes

No clinical evidence of satellite lesions or intransit, regional nodal or
distant metastases 

No second primary invasive melanoma

Prior/Concurrent Therapy:

Biologic therapy:
 No prior immunotherapy
 Patients receiving wide excision alone:
  No concurrent interferon alfa as initial treatment

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 At least 6 months since prior oral or parenteral steroids

Radiotherapy:
 No prior radiotherapy

Surgery:
 No greater than 10 weeks since biopsy
 No prior wide excision of the primary at least 3.0 cm in diameter with the
  shortest tumor-excision margin at least 1.5 cm
 No prior elliptical excision of the primary with shortest tumor-excision edge
  at least 1.5 cm
 No prior organ transplantation consequently requiring immunosuppressive
  agents
 No prior skin grafts, tissue transfers or flaps, or lymph node dissection
  that may alter the lymphatic drainage pattern from a primary cutaneous
  melanoma to the adjacent regional lymph node basins

Other:
 At least 6 months since any prior immunosuppressive drugs

Patient Characteristics:

Age:
 18 to 75

Performance status:
 Not specified

Life expectancy:
 At least 10 years from time of diagnosis, excluding the diagnosis of melanoma

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No known primary or secondary immune deficiencies
 No evidence that patients cannot undergo selective lymph node dissection for
  any reason
 No other medical condition that will affect life expectancy
 No other malignancy in the past 5 years except squamous cell carcinoma of the
  skin, basal cell carcinoma, or in situ carcinoma of the uterine cervix that 
  has been adequately treated more than 6 months ago for T1 lesions
 Not pregnant

Expected Enrollment

There will be 1,600 patients accrued into this study (60% into arm I and 40% 
into arm II).

Outline

This is a randomized, prospective, multicenter study.  Patients are stratified 
by primary site (extremity vs nonextremity) and by Breslow thickness 
(1.20-1.79 mm vs 1.80-3.50 mm).

Patients are randomized to receive wide excision with intraoperative lymphatic 
mapping and selective lymph node dissection (arm I) or wide excision alone 
(arm II).

Patients in arm I undergo preoperative lymphoscintigraphy.  Patients with 
positive lymph nodes after intraoperative lymphatic mapping and selective 
lymph node dissection undergo complete lymph node dissection.
 
All patients are followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

John Wayne Cancer Institute at Saint John's Health Center

Donald Morton, MD, Protocol chair		Ph: 310-829-8363

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