Trial record 1 of 2 for:    MSLT-II
Previous Study | Return to List | Next Study

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

  Show 64 Study Locations
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 September 30, 2014