Multicenter Selective Lymphadenectomy Trial II (MSLT-II)



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:2/8/2018
Start Date:September 2004
End Date:September 2022

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A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection Versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients With Molecular or Histopathological Evidence of Metastases in the Sentinel Node

Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If
the subject is sentinel node positive and meets study requirements, the subject is randomized
to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound.
Subjects are then followed for 10 years.


Inclusion Criteria:

1. Ability to provide informed consent.

2. Between 18 and 75 years of age.

3. Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity,
scalp, palm, sole, subungual skin tissues).

4. Have clear margins following WLE.

5. ECOG performance status 0-1.

6. Life expectancy of at least 10 years from the time of diagnosis, not considering the
melanoma in question, as determined by the PI.

7. Willing to return to the MSLT-II center for follow up examinations and procedures as
outlined in the protocol.

8. Randomization and/or CLND (as appropriate to randomization arm) must be completed no
more than 120 days following the diagnostic biopsy of the primary melanoma.

9. Have a melanoma-related tumor-positive SN, determined by either of the following
methods:

1. Diagnosis of tumor-positive SN by MSLT-II center institutional pathologist by
either H&E or IHC (using S-100, Mart-1, and HMB-45).

2. Diagnosis of tumor-positive SN by RT-PCR analysis performed at JWCI, provided the
primary melanoma fits into one of the following categories:

- Breslow thickness of 1.20 mm or greater and Clark Level III

- Clark Level IV or V, regardless of Breslow thickness

- Ulceration, regardless of Breslow thickness or Clark level

Exclusion Criteria:

1. History of previous or concurrent (i.e., second primary) invasive melanoma.

2. Primary melanoma of the eye, ears, mucous membranes or internal viscera. (Primary of
the skin of the external ear is acceptable.)

3. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit,
regional, or distant metastatic disease.

4. Any additional solid tumor or hematologic malignancy during the past 5 years except T1
skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical
cancer.

5. Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic
drainage pattern from the primary melanoma to a LN basin.

6. Allergy to vital blue dye or any radiocolloid.

7. Inability to localize 1-2 SN drainage basins via LM (e.g., no basins found, more than
2 basins found, proximity of the primary melanoma to the regional draining basin,
etc.)

8. CLNDs or SLs (before evaluation of the current melanoma) that may have altered the
lymphatic drainage pattern from the primary cutaneous melanoma to a potential LN
basin.

9. Organic brain syndrome or significant impairment of basal cognitive function or any
psychiatric disorder that might preclude participation in the full protocol, or be
exacerbated by therapy (e.g., severe depression).

10. Melanoma-related operative procedures not corresponding to criteria described in the
protocol.

11. Primary or secondary immune deficiencies or known significant autoimmune disease.

12. History of organ transplantation.

13. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any
time during study participation or within 6 months prior to enrollment.

14. Pregnant or lactating women.

15. Participation in concurrent therapy protocols of alternative local nodal basin
therapies that might confound the analysis of this trial is not permitted. For
example, radiation of a non-resected node basin is not acceptable because it might
influence outgrowth of residual melanoma in that nodal basin. However, systemic
adjuvant therapy or clinical trial adjuvant protocols after the finding of a positive
node on LM/SL or delayed nodal recurrence in the ultrasound observation arm are both
acceptable according to the standard of care at the multicenter site. Patients with
positive sentinel nodes or thick primary melanomas who are considered by the
multicenter site's investigator as high-risk may receive systemic adjuvant therapy
according to the standard practice of that particular site.

16. SLND pathology shows, on microscopic examination, that melanoma extends through the
lymph node capsule into the adjacent soft tissue.
We found this trial at
41
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3525
Lakeland, Florida 33805
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 21287
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Bethlehem, Pennsylvania 18015
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Buffalo, New York
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chicago, Illinois 60612
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Colorado Springs, Colorado 80903
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, Texas 75235
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Danville, Pennsylvania 17882
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Great Neck, New York 11021
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Greenville, South Carolina 29605
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Knoxville, Tennessee 37920
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newcastle, New South Wales
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Newport News, Virginia 23606
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Peoria, Illinois 61637
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Philadelphia, Pennsylvania 19111
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84112
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San Diego, California 92123
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Stony Brook, New York 11794
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Tampa, Florida 33612
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Winston-Salem, North Carolina 27157
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Wynnewood, Pennsylvania 19096
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