Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Chronic Graft Versus Host Disease

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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 Dasatinib daily continued up to 12 months/12 cycles (1 cycle = 4 weeks of treatment).

Surgical Resection

Kevin B. Kim, MD, BA

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:

1. To assess the safety and tolerability of dasatinib in this patient population

   Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma:
2. To assess the median time to recurrence and overall survival of patients with completely resectable acral, CSD, and mucosal melanoma treated with dasatinib
3. 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:
4. To assess the response rate, progression free survival, and overall survival of patients with acral, CSD, and mucosal melanoma treated with dasatinib
5. 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:

* Your weight and vital signs will be measured.
* You will be asked about any drugs you may be taking.
* Your performance status will be recorded.

After 7 days of taking the study drug, and before surgery, the following procedures will be performed:

* You will have a physical exam, including a measurement of your weight and vital signs.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking.
* You will have an ECG to check your heart function.
* You will have a PET scan to check the status of the disease.

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:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have a physical exam, including a measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking, and any side effects you may be experiencing.

On Day 15 of Cycle 1 only, the following tests and procedures will be performed:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have a physical exam, including a measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking, and any side effects you may be experiencing.

Every 12 weeks while you are receiving treatment, the following tests and procedures will be performed:

* An ECG will be performed to check your heart function.
* You will have a CT scan or MRI scan of the chest, abdomen, and pelvis to check the status of the disease.

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:

* You will have a measurement of your vital signs including your weight.
* You will be asked about any drugs you may be taking.
* Your performance status will be recorded.

After 7 days of taking the study drug, and before the biopsy, the following procedures will be performed:

* You will have a physical exam, including a measurement of your weight and vital signs.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking.
* You will have an ECG to check your heart function.
* You will have a PET scan to check the status of the disease.

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:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have a physical exam including a measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking, and any side effects you may be experiencing.

The following tests and procedures will be performed on Day 1 of each cycle starting with Cycle 2:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have a physical exam, including a measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking, and any side effects you may be experiencing.

Every 12 weeks while you are receiving treatment, the following tests and procedures will be performed:

* An ECG will be performed to check your heart function.
* You will have a CT scan or MRI scan of the chest, abdomen, and pelvis to check on the status of the disease.

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:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* An ECG will be performed to check your heart function.
* You will have a CT scan or MRI scan of your chest, abdomen, and pelvis performed to check the status of the disease.
* You will have a physical exam, including a measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any other drugs you may be taking, and any side effects you may be experiencing.

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.

Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

A Phase II Study of Biological Response to Dasatinib Treatment in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

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 (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.

Bristol-Myers Squibb

M.D. Anderson Cancer Center

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).

Dasatinib + Completely Resectable

Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).

Dasatinib + Unresectable

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

One participant was screen-failed prior to study group entry.

Kevin Kim, MD/Melanoma Medical Oncology

Complete Metabolic Response

Partial Metabolic Response

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).

Biologic Response Evaluation of Tumors With and Without Resectable Tumors

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.

Progression-Free Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma	NCT01092728	Melanoma	Dasatinib Surgical Resect...	18 Years -	M.D. Anderson Cancer Center
Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma	NCT01092728	Melanoma	Dasatinib Surgical Resect...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for surgically removed tumor