Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma. The safety of this drug will also be studied.
1. To compare the biological response of tumors With and Without Resectable Tumors from patients with acral, or mucosal melanomas after treatment with dasatinib.
To assess the safety and tolerability of dasatinib in this patient population
Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma:
- To assess the median time to recurrence and overall survival of patients with completely resectable acral, CSD, and mucosal melanoma treated with dasatinib
To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts prolonged time to recurrence and/or overall survival in patients with completely resectable acral, CSD, and mucosal melanomas
Not Completely Resectable Acral, CSD, and Mucosal Melanoma:
- To assess the response rate, progression free survival, and overall survival of patients with acral, CSD, and mucosal melanoma treated with dasatinib
- To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts response rate, progression free survival, and/or overall survival in patients with acral, CSD, and mucosal melanomas
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Biological Response to Dasatinib Treatment in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma|
- Biologic Response Evaluation of Tumors With and Without Resectable Tumors [ Time Frame: Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards ] [ Designated as safety issue: No ]
Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, >/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without >15% increase in tumoral Ki-67 expression or >/=25% decrease in tumoral Ki-67 expression without >15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): >/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image & adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background.
PR or CR confirmatory disease assessment performed >4 weeks (28 days) after criteria for response first met.
- Progression-Free Survival [ Time Frame: Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years ] [ Designated as safety issue: No ]Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.
|Study Start Date:||March 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Group 1: Completely Resectable
Dasatinib 100 mg daily for 7 days and then surgical resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
100 mg daily.
Other Names:Procedure: Surgical Resection
Complete surgical resection of tumor(s).
Active Comparator: Group 2: Unresectable
100 mg Dasatinib daily continued up to 12 months/12 cycles (1 cycle = 4 weeks of treatment).
100 mg daily.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092728
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Kevin B. Kim, MD, BA||UT MD Anderson Cancer Center|