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Melanoma

Lymph Node Dissection/Observation for Localized Melanoma (7108)
Multicenter Selective Lymphadenectomy for Melanoma Trial II: 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 [Randomization phase]
Status Conditions Phase Study ID
Closed Melanoma Phase III 7108
NCT00389571
Summary

RATIONALE: Lymph node dissection may remove tumor cells that have spread to nearby lymph nodes in patients with localized melanoma. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether complete lymph node dissection is more effective than observation in treating patients with localized melanoma who have undergone sentinel lymphadenectomy.

PURPOSE: This randomized phase III trial is studying complete lymph node dissection to see how well it works compared to observation in treating patients with localized melanoma and sentinel node metastasis who have undergone sentinel lymphadenectomy.


Investigator
David Byrd, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary localized cutaneous melanoma involving the head, neck, trunk, extremity, scalp, palm, sole, or subungual skin tissues

    • No primary melanoma of the eye, ear, mucous membranes, or internal viscera
    • Has undergone diagnostic biopsy of the primary melanoma within the past 120 days
  • Tumor-positive sentinel node (SN)*, as determined by either of the following methods:

    • Hematoxylin and eosin (H&E) staining or immunohistochemistry using S-100, MART-1, and HMB-45
    • Reverse transcriptase-polymerase chain reaction (RT-PCR) allowed provided the primary melanoma meets 1 of the following criteria:

      • Breslow thickness ≥ 1.20 mm and Clark level III
      • Clark level IV or V, regardless of Breslow thickness
      • Ulceration, regardless of Breslow thickness or Clark level NOTE: *Patients with tumor-negative SNs will be followed annually
  • Has undergone lymphatic mapping (LM) followed by sentinel lymphadenectomy (SL) and wide local excision (WLE) (prior to randomization)**

    • Able to localize 1-2 SN drainage basins by preoperative lymphoscintigraphy
    • Must have clear margins after undergoing WLE NOTE: **Patients may enter study prior to undergoing LM, SL, and WLE but must undergo these procedures prior to randomization
  • No prior or concurrent (i.e., secondary primary) invasive melanoma
  • No physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 10 years from the time of diagnosis (not considering the melanoma in question)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other solid tumor or hematologic malignancy within the past 5 years except for squamous cell or basal cell carcinoma T1 skin lesions or cervical cancer
  • No allergy to vital blue dye or any radiocolloid
  • No organic brain syndrome or significant impairment of basal cognitive function
  • No psychiatric disorder that would preclude study participation or be exacerbated by therapy (e.g., severe depression)
  • No primary or secondary immune deficiencies or known significant autoimmune disease

PRIOR CONCURRENT THERAPY:

  • No prior complete lymph node dissection (CLND) or SL that may have altered the lymphatic drainage pattern from the primary cutaneous melanoma to a potential lymph node basin
  • No prior organ transplantation
  • More than 6 months since prior and no concurrent oral or parenteral immunosuppressive agents (except for topical or inhaled steroids)
  • No prior skin grafts or tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary tumor to a lymph node basin
  • No concurrent melanoma-related operative procedures not corresponding to criteria described in the protocol
  • No concurrent participation in another experimental protocol that might confound trial analysis

    • Participation in adjuvant therapy protocols after disease recurrence allowed
  • No concurrent alternative therapies that might confound trial analysis
Last Updated
April 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.