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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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


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.

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 experimental protocols or alternative therapies that
might confound the analysis of this trial. Adjuvant therapy protocols after
recurrence are acceptable.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Donald L. Morton, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

John Wayne Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

MSLT-II

NCT ID:

NCT00297895

Start Date:

September 2004

Completion Date:

September 2022

Related Keywords:

  • Melanoma
  • sentinel lymph node dissection
  • complete lymph node dissection
  • surgical
  • Melanoma

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
John Wayne Cancer InstituteSanta Monica, California  90404
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
University of WashingtonSeattle, Washington  98195
University of VirginiaCharlottesville, Virginia  22908
Vanderbilt UniversityNashville, Tennessee  37232-6305
Duke University Medical CenterDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Lakeland Regional Cancer CenterLakeland, Florida  33805
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Ohio State UniversityColumbus, Ohio  43210
University of LouisvilleLouisville, Kentucky  40202
University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Johns Hopkins Medical InstituteBaltimore, Maryland  21231
Mercy Medical CenterBaltimore, Maryland  21202
St. Louis UniversitySt. Louis, Missouri  63110
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Sharp HospitalSan Diego, California  92123
University of WisconsinMadison,, Wisconsin  53792-5666
University of CincinnatiCincinnati, Ohio  45267-0502
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Columbia University Medical CenterNew York, New York  10032
Hunstman Cancer InstituteSalt Lake City, Utah  84112
University of Tennessee Medical CenterKnoxville, Tennessee  37920
Rush UniversityChicago, Illinois  60612
Memorial Hospital - Colorado SpringsColorado Springs, Colorado  809030-3658
Buffalo General HospitalBuffalo, New York  14209
New York Hospital - QueensFlushing, New York  11355
SUNY at Stony Brook Hospital Medical CenterStony Brook, New York  11794-8191
St. Luke's HospitalBethlehem, Pennsylvania  18015
Geisinger ClinicDanville, Pennsylvania  17822
Pennsylvania State Hershey Cancer InstituteHershey, Pennsylvania  17033
Main Line SurgeonsWynnewood, Pennsylvania  19096
Dallas Surgical GroupDallas, Texas  75235
IHC Cancer Services Intermountain Medical CenterSalt Lake City, Utah  84103
Sentara Careplex HospitalNewport News, Virginia  23606
Feinstein Institute for Medical ResearchManhassett, New York  11030