Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Wayne Cancer Institute
ClinicalTrials.gov Identifier:
NCT00297895
First received: February 27, 2006
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Procedure: Completion Lymphadenectomy
Procedure: Monitoring with nodal ultrasound
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by John Wayne Cancer Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival over 10 years of follow up [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Recurrence during 10 years of follow up [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1925
Study Start Date: September 2004
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound observation + delayed CLND if recurrence detected Procedure: Monitoring with nodal ultrasound
serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
Active Comparator: CLND Procedure: Completion Lymphadenectomy
complete lymph node dissection of lymph node basin with positive node

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297895

  Hide Study Locations
Locations
United States, California
Sharp Hospital
San Diego, California, United States, 92123
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Colorado
Memorial Hospital - Colorado Springs
Colorado Springs, Colorado, United States, 809030-3658
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush University
Chicago, Illinois, United States, 60612-3824
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61603-3135
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0932
United States, Missouri
St. Louis University
Saint Louis, Missouri, United States, 63110-8566
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Buffalo General Hospital
Buffalo, New York, United States, 14209
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Feinstein Institute for Medical Research
Great Neck, New York, United States, 11021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
SUNY at Stony Brook Hospital Medical Center
Stony Brook, New York, United States, 11794-8191
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadephia, Pennsylvania, United States, 19111
Main Line Surgeons
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Vanderbilt University
Nashville, Tennessee, United States, 37232-6868
United States, Texas
Dallas Surgical Group
Dallas, Texas, United States, 75235
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Hunstman Cancer Institute
Salt Lake City, Utah, United States, 84112
IHC Cancer Services Intermountain Medical Center
Salt Lake City, Utah, United States, 84103
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sentara Careplex Hospital
Newport News, Virginia, United States, 23606
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Newcastle Melanoma Unit
Newcastle, New South Wales, Australia, 2298
Melanoma Institute Australia
Sydney, New South Wales, Australia, 2060
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Alfred Hospital
East Hawthorn, Victoria, Australia, 3123
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3677
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N3M5
Finland
Helsinki Unversity Hospital
Helsinki, Finland, 00029 HUS
Germany
U. Hosp. Schleswig-Holstein/Campus Lubeck
Lubeck, Germany, 23538
City Hospital of Nurnberg
Nurnberg, Germany, 90419
University of Wurzburg
Wurzburg, Germany, 97080
Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 94239
Italy
Istituto Europeo di Oncologia
Milan, Italy, 20141
Istituto Nazionale dei Tumori Napoli
Naples, Italy, 80121
Istituto Oncologico Veneto - University of Padova
Padova, Italy, 35128
Padua University - Clinica Chirurgica II
Padua, Italy, 35128
Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700 RB
Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Sweden
Swedish Melanoma Study Group
Lund, Sweden, S-221 85
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH 1011
University of Zurich
Zurich, Switzerland, CH-8091
United Kingdom
Norfolk and Norwich University Hospital
Norfolk, Norwich, United Kingdom, NR4 7UY
Saint Thomas's Hospital
London, United Kingdom, SE17EH
Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
Study Chair: Mark B. Faries, M.D. John Wayne Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT00297895     History of Changes
Obsolete Identifiers: NCT00389571
Other Study ID Numbers: MSLT-II, NIH P01 CA029605
Study First Received: February 27, 2006
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by John Wayne Cancer Institute:
sentinel lymph node dissection
complete lymph node dissection
surgical

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 29, 2014