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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00468 | Registry Identifier | NCI CTRP |
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Slow accrual.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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:
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
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 record when you take the study drug, and how many pills you take each time. You will need to bring the pill chart to every study visit for the study doctor to review. You will also need to bring the pill bottles to each study visit.
Group 1 Study Visits:
After the screening tests have been complete, and before you start taking the study drug, the following procedures will be performed:
After 7 days of taking the study drug, and before surgery, the following procedures will be performed:
About 6 weeks after surgery, when you begin taking the study drug on Cycle 1, the following tests and procedures will be performed on Day 1 of each cycle:
On Day 15 of Cycle 1 only, the following tests and procedures will be performed:
Every 12 weeks while you are receiving treatment, the following tests and procedures will be performed:
Group 2 Study Visits:
After the screening tests have been complete, and before you start taking the study drug, the following procedures will be performed:
After 7 days of taking the study drug, and before the biopsy, the following procedures will be performed:
About 5 days after the biopsy, you will begin taking the study drug again for 3 more weeks to complete Cycle 1. On Day 15 of Cycle 1 only, the following tests and procedures will be performed:
The following tests and procedures will be performed on Day 1 of each cycle starting with Cycle 2:
Every 12 weeks while you are receiving treatment, the following tests and procedures will be performed:
Length of Study:
You will continue to take the study drug for up to 13 cycles. You will be taken off study early if you experience intolerable side effects, the disease returns (Group 1 only), the disease gets worse (Group 2 only), or if the study doctor thinks it is in your best interest.
If you are in Group 2, and you are benefiting from the treatment, you may be allowed to continue to receive treatment with the study drug after you have completed the 12 study cycles. The study doctor will discuss this option with you in more detail.
End-of-Study Visit:
Within 30 days after the last dose of study drug, you will have an end-of-study visit, at which the following tests and procedures will be performed:
Follow-Up Visits:
After your participation on this study is complete, you will have follow-up visit every 3 months and you will be asked about your health status. If you do not come to the hospital for a regularly scheduled clinic visit, you will receive a follow-up phone call. The phone call should last about 15 minutes each time.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of certain types of leukemia. The use of dasatinib to treat acral lentiginous melanoma, mucosal melanoma, or chronic sun-damaged melanoma is investigational.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Completely Resectable | Active Comparator | 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). |
|
| Group 2: Unresectable | Active Comparator | 100 mg Dasatinib daily continued up to 12 months/12 cycles (1 cycle = 4 weeks of treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | 100 mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biologic Response Evaluation of Tumors With and Without Resectable Tumors | 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. | Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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. | Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin B. Kim, MD, BA | UT MD Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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A total of 19 participants were enrolled, out of which 18 participants were included in the analysis and 1 participant was a screen failure.
Recruitment Period: March 2011 to September 2013. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib + Completely Resectable | Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor 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). |
| FG001 | Dasatinib + Unresectable | Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant was screen-failed prior to study group entry.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib + Completely Resectable | Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor 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). |
| BG001 | Dasatinib + Unresectable |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biologic Response Evaluation of Tumors With and Without Resectable Tumors | 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. | Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal). | Posted | Number | participants | Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards |
Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib + Completely Resectable | Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet Count Decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Kim, MD/Melanoma Medical Oncology | The University of Texas (UT) MD Anderson Cancer Center | 1-877-MDA-6789 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Surgical Resection | Procedure | Complete surgical resection of tumor(s). |
|
| Disease Progression |
|
| Prohibited Concomitant Medications |
|
Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Progression-Free Survival | 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. | None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study. | Posted | Median | Full Range | Weeks | Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years |
|
|
|
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Dasatinib + Unresectable | Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment). | 4 | 14 | 14 | 14 |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal Hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin Decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema Limbs | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood Glucose Increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophil Count Decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Serum Potassium Decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight Gain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash Desquamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional Symptoms | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Localized Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage/Bleeding | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |