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Multicenter Selective Lymphadenectomy Trial (MSLT II) in Melanoma

Award Number: R01CA189163
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2019

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Multicenter Selective Lymphadenectomy Trial (MSLT II) in Melanoma - DESCRIPTION (provided by applicant): Lymph node management in melanoma has been controversial for over 100 years. Earlier findings of our study group have contributed to current understanding of several cancers and have established current standards for treatment of melanoma with improved prognostic assessment, identification of patients for appropriate interventions, and prevention of treatment-related morbidity. The current proposal will complete the definition of optimal surgical therapy of regional lymph nodes. These aims will be achieved through the second Multicenter Selective Lymphadenectomy Trial (MSLT2). Aim 1) To determine if immediate completion lymph node dissection enhances the outcomes of patients with melanoma sentinel node metastases The primary endpoint of MSLT2 is melanoma-specific survival comparing patients with positive sentinel lymph nodes (SLN) who are treated by immediate completion lymph node dissection (CLND) to those who are followed using clinical and ultrasound examination. Secondary endpoints include disease-free survival, time to recurrence in the regional lymph node basin, quality of life, and safety. Aim 2) To establish and validate optimal methods of SLN evaluation and prognosis determination Although SLN biopsy has improved staging accuracy in melanoma, "gold standard" methods for SLN evaluation are not established. The rich data available in trial databases have allowed evaluation of several leading candidate parameters for nodal assessment and prognosis. MSLT2 will validate the methods and allow more precise determination of the need for more therapy or follow up. Aim 3) To determine the utility of novel, currently non-standard evaluation measures: 3a) RT-PCR evaluation of SLN: Some patients with SLN that are negative by standard pathologic evaluation recur and die of melanoma. Retrospective studies suggest that RT-PCR evaluation of lymph nodes can discriminate patients who are or are not at substantial risk of recurrence. Validation of these data prospectively in MSLT2 has the potential to revolutionize SLN evaluation. 3b) Ultrasound follow up of at-risk nodal basins: MSLT2 is systematically evaluating the utility of serial ultrasound of lymph node basins in which a positive sentinel node was identified. The significance of these objectives cannot be overstated. MSLT1 has spared many patients unnecessary surgery, morbidity, anxiety and expense. The current trial will establish a similar standard for patients with sentinel node metastases and either confirm the need for immediate CLND or allow the majority of patients to avoid it.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	5	2/18/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,372,351 )
2018	2018	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	5	8/14/2018	NON-COMPETING CONTINUATION	$1,372,351
														Subtotal = $1,372,351

Issue Date FY: 2017 ( Subtotal = $1,507,063 )
2017	2017	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	4	8/15/2017	NON-COMPETING CONTINUATION	$1,507,063
														Subtotal = $1,507,063

Issue Date FY: 2016 ( Subtotal = $1,682,114 )
2016	2016	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	3	8/10/2016	NON-COMPETING CONTINUATION	$1,682,114
														Subtotal = $1,682,114

Issue Date FY: 2015 ( Subtotal = $1,769,133 )
2015	2015	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	2	8/28/2015	NON-COMPETING CONTINUATION	$1,769,133
														Subtotal = $1,769,133

Issue Date FY: 2014 ( Subtotal = $1,780,788 )
2014	2014	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	1	9/23/2014	NEW	$1,780,788
														Subtotal = $1,780,788

Grand Total All Awards = $8,111,449

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Multicenter Selective Lymphadenectomy Trial (MSLT II) in Melanoma

Award Number: R01CA189163

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/23/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2019

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