Clinical trial NCT01092728
Conditions: Melanoma
Keywords: Acral lentiginous melanoma Mucosal melanoma Chronic sun-damaged melanoma Surgically removed tumor biopsied Sprycel Dasatinib
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-03-01; Completion date: 2014-08-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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:

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

Detailed description:
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.

Arms: arm 1: 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). arm 2: 100 mg Dasatinib daily continued up to 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Interventions: intervention 1: Dasatinib intervention 2: Surgical Resection
Intervention descriptions: intervention 1: 100 mg daily. intervention 2: Complete surgical resection of tumor(s).

Protocol documents: