Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297895
• Other study ID #: MSLT-II
• Secondary ID: P01CA029605R01CA
• Status: Completed
• Phase: N/A
• Start date: September 30, 2004
• Est. completion date: September 30, 2019

Study information

• Verified date: May 2022
• Source: Saint John's Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00389571

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1939
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Procedure:
• Completion Lymphadenectomy
complete lymph node dissection of lymph node basin with positive node
• Monitoring with nodal ultrasound
serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.

Locations

Country	Name	City	State
Australia	Alfred Hospital	East Hawthorn	Victoria
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Newcastle Melanoma Unit	Newcastle	New South Wales
Australia	Melanoma Institute Australia	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
Finland	Helsinki Unversity Hospital	Helsinki
Germany	U. Hosp. Schleswig-Holstein/Campus Lubeck	Lubeck
Germany	City Hospital of Nurnberg	Nurnberg
Germany	University of Wurzburg	Wurzburg
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Italy	Istituto Europeo di Oncologia	Milan
Italy	Istituto Nazionale dei Tumori Napoli	Naples
Italy	Istituto Oncologico Veneto - University of Padova	Padova
Italy	Padua University - Clinica Chirurgica II	Padua
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Spain	Hospital Clinic Barcelona	Barcelona
Sweden	Swedish Melanoma Study Group	Lund
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	University of Zurich	Zurich
United Kingdom	Saint Thomas's Hospital	London
United Kingdom	Norfolk and Norwich University Hospital	Norfolk	Norwich
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Medical Institute	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Buffalo General Hospital	Buffalo	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Memorial Hospital - Colorado Springs	Colorado Springs	Colorado
United States	Ohio State University	Columbus	Ohio
United States	Dallas Surgical Group	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Feinstein Institute for Medical Research	Great Neck	New York
United States	Greenville Hospital System Cancer Center	Greenville	South Carolina
United States	Pennsylvania State Hershey Cancer Institute	Hershey	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Sentara Careplex Hospital	Newport News	Virginia
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	St. Louis University	Saint Louis	Missouri
United States	Hunstman Cancer Institute	Salt Lake City	Utah
United States	IHC Cancer Services Intermountain Medical Center	Salt Lake City	Utah
United States	Sharp Hospital	San Diego	California
United States	John Wayne Cancer Institute	Santa Monica	California
United States	University of Washington	Seattle	Washington
United States	SUNY at Stony Brook Hospital Medical Center	Stony Brook	New York
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina
United States	Main Line Surgeons	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Saint John's Cancer Institute	National Cancer Institute (NCI), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Finland,  Germany,  Israel,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melanoma-specific survival. This is defined as the time between the date of a subject's randomization (or date of CLND for those randomized to the CLND arm) and the date of death due to melanoma. Subjects are followed until death or 10yrs.		10 years
Secondary	Disease-free survival over 10 years of follow up		10 years
Secondary	Recurrence during 10 years of follow up		10 years

External Links

•   John Wayne Cancer Institute Clinical Trials (sponsor)