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

2014-08-27 03:14:59 | BioPortfolio

Summary

The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can help to control the tumor in patients whose tumor has a gene abnormality known as a "CKIT mutation" to patients whose tumor does not have a CKIT mutation. The safety of this drug will also be studied.

Primary Objectives

1. To compare the biological response of tumors harboring exon 11 or 13 KIT mutations versus tumors without exon 11 or 13 KIT mutations from patients with acral, chronic sun-damaged, and mucosal melanomas after treatment with dasatinib.

Secondary Objectives

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

2. To evaluate molecular changes of tumors harboring exon 11 or 13 KIT mutations versus tumors without KIT exon 11 or 13 mutations from patients with acral, chronic sun-damaged, and mucosal melanomas after treatment with dasatinib by assessing apoptosis, autophagy and cell proliferation markers

3. To assess the secondary mutations that may account for resistance to dasatinib therapy

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.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. If some of these tests have been performed recently, they may not need to be repeated. The following tests and procedures will be performed within 14 days before you may begin treatment with the study drug:

- Your medical history will be recorded, including any drugs you may be taking.

- Your demographic information (such as your race and gender) will be recorded.

- You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, breathing rate, heart rate, and temperature).

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- You will be asked about any symptoms you might be experiencing

- Blood (about 2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.

- You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart).

- You will have a computed tomography (CT) scan and/or magnetic resonance imaging (MRI) scan of the head, chest, abdomen, and pelvis to check the status of the disease.

- You will have a positron emission tomography (PET) scan performed to check the status of the disease.

- Tumor tissue left over from a procedure performed in the past 3 months will be collected and used to check the status of the disease. If leftover tumor tissue is not available, you will have a tumor biopsy to collect tissue. To collect a tumor biopsy, the tumor area is numbed with anesthetic, and a small amount of tumor is withdrawn through a large needle.

The study doctor will discuss the screening results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

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 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.

Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

Dasatinib

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:59-0400

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