Clinical Trial: Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study of Biological Response to Dasatinib Treatment in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
Brief Summary:
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.
Objectives:
Primary Objectives:
1. To compare the biological response of tumors With and Without Resectable Tumors from patients with acral, or mucosal melanomas after treatment with dasatinib.
Secondary Objectives:
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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
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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,
Detailed Summary:
The Study Drug:
Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.
Study Groups:
If you are found to be eligible to take part in this study, you will be placed into one of two groups depending on if the disease can be removed by surgery on or not. Group 1 will be patients who have melanoma that can be removed by surgery. Group 2 will be patients who have melanoma that cannot be completely removed by surgery.
Study Drug Administration:
For this study, every 4 weeks is a study "cycle."
Dasatinib pills will be taken by mouth with a full glass (8 ounces) of water with or without a meal. The pills should not be crushed or cut, they should be swallowed whole.
If you are in Group 1, you will take 2 dasatinib pills 1 time every day, for 7 days before your already-scheduled surgery. About 6 weeks after surgery (depending on how long it takes you to recover) you will begin taking 2 dasatinib pills 1 time every day for up to 13 cycles as long as you tolerate it and the disease does not come back.
If you are in Group 2, you will take 2 dasatinib pills 1 time every day, for 7 days before your already-scheduled biopsy on Day 8 (+/1 business day) of Cycle 1. Within 5 days after the biopsy, you will begin taking 2 dasatinib pills 1 time every day for up to 13 cycles, as long as you tolerate it and the disease does not come back.
Both groups will be given a pill chart to fill out at home to re
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: 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 ]
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.
Original Primary Outcome: Comparison of Biologic Response of Patient Tumors with and without Exon 11 or 13 KIT Mutations [ Time Frame: Baseline to 7 Days ]
Biologic response defined as either a (complete or partial) metabolic response or a molecular response after 7 days of dasatinib treatment.
Current Secondary Outcome: Progression-Free Survival [ Time Frame: Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years ]
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.
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: March 23, 2010
Date Started: March 2011
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016
