Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

Recruiting

• Source

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  Public Title	Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT00297895

• Trial

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  Health Condition(s) or Problem	Melanoma
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	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.
  Who cannot enter the trial	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.
  What will happen	Procedure; Completion Lymphadenectomy; complete lymph node dissection of lymph node basin with positive node; CLND; Procedure; Monitoring with nodal ultrasound; serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.; Ultrasound observation + delayed CLND if recurrence detected
  Primary aim	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.
  Secondary Aim	Disease-free survival over 10 years of follow up; 10 years; No; Recurrence during 10 years of follow up; 10 years; No
  Participant Information Sheet	Sorry, not currently available
  Website	http://www.jwci.org/open-trials.aspx
  Recruitment Status	Recruiting
  Nation	England
  Location	Norwich, London

• Contact

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  Contact for Public Queries

  Donald Morton, M.D. 310-829-8363 mortond@jwci.org Donald L. Morton, M.D. Study Chair John Wayne Cancer Institute

  Contact for Scientific Queries

  Robert Barone, M.D.; Principal Investigator; Donald L. Morton, M.D.; Principal Investigator; Larry Dillon, M.D.; Principal Investigator; Helen Chan, M.D.; Principal Investigator; Jonathan Zager, M.D.; Principal Investigator; Jeffrey Wayne, MD; Principal Investigator; Howard Kaufman, M.D.; Principal Investigator; Norman Estes, M.D.; Principal Investigator; Kelly McMasters, M.D.; Principal Investigator; Armando Sardi, M.D.; Principal Investigator; Charles Balch, M.D.; Principal Investigator; Michael Sabel, M.D.; Principal Investigator; Eddy Hsueh, M.D.; Principal Investigator; Richard Barth, M.D.; Principal Investigator; John Kane, M.D.; Principal Investigator; Mitchell Chorost, MD; Principal Investigator; Mansoor Beg, M.D.; Principal Investigator; Charlotte Ariyan, MD; Principal Investigator; Bret Taback, M.D.; Principal Investigator; Colette Pameijer, MD; Principal Investigator; Randall Scheri, MD; Principal Investigator; Edward Levine, M.D.; Principal Investigator; Doreen Agnese, M.D.; Principal Investigator; Darius Desai, M.D.; Principal Investigator; Joseph Blansfield, MD; Principal Investigator; Rogerio Neves, MD; Principal Investigator; Giorgos Karakousis, M.D.; Principal Investigator; Adam Berger, MD; Principal Investigator; Jeffrey Farma, MD; Principal Investigator; Ned Carp, M.D.; Principal Investigator; Steven D. Trocha, M.D.; Principal Investigator; James Lewis, MD; Principal Investigator; Peter Beitsch, M.D.; Principal Investigator; Jeffrey Gershenwald, M.D.; Principal Investigator; Robert Andtbacka, M.D.; Principal Investigator; Tawnya Bowles, M.D.; Principal Investigator; Craig Slingluff, MD; Principal Investigator; Richard Hoefer, MD; Principal Investigator; David Byrd, M.D.; Principal Investigator; Heather Neuman, M.D.; Principal Investigator; Peter Hersey, M.D.; Principal Investigator; John Thompson, MBBS, FRACS, FACS; Principal Investigator; Mark Smithers, M.D.; Principal Investigator; Michael Henderson, MD; Principal Investigator; Gregory McKinnon, M.D.; Principal Investigator; Frances Wright, MD; Principal Investigator; Tiina Jahkola, M.D.; Principal Investigator; Patrick Terheyden, MD; Principal Investigator; Erwin Schultz, M.D.; Principal Investigator; Anja Gesierich, M.D.; Principal Investigator; Schlomo Schneebaum, M.D.; Principal Investigator; Alessandro Testori, M.D.; Principal Investigator; Nicola Mozzillo, M.D.; Principal Investigator; Mirto Foletto, M.D.; Principal Investigator; Omgo Nieweg, MD; Principal Investigator; H. J. Hoekstra, M.D., Ph.D; Principal Investigator; Sergi Vidal-Sicart, MD; Principal Investigator; Christian Ingvar, M.D.; Principal Investigator; Maurice Matter, M.D.; Principal Investigator; Reinhard Dummer, MD; Principal Investigator; Marc Moncrieff, MD; Principal Investigator; Mark Harries, M.D.; Principal Investigator