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Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)

2014-08-27 03:13:45 | BioPortfolio

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.

Description

The Study Drugs:

Sunitinib is designed to block pathways that control important events (such as the growth of blood vessels) that are essential for the growth of cancer.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

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. The following tests and procedures will be performed within 4 weeks before you can begin receiving the study drugs:

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

- You will have an MRI scan and/or a CT scan of your brain to check the status of the disease.

- You will have an echocardiogram or a multi-gated acquisition (MUGA) scan to check your heart's health.

The following tests and procedures will be performed within 1 week before you can begin receiving the study drugs:

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

- 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).

- Blood (about 3 teaspoons) and urine will be collected for routine tests. This blood will also be used to check your thyroid function and it will include a pregnancy test for women who are able to have children. To take part in this study, the pregnancy test must be negative.

The study doctor will discuss the screening test 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 options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of sunitinib and temsirolimus based on when you joined this study. There will be 2 stages in this study.

Up to 5 dose levels of the study drug combination will be tested in Stage 1. Two (2) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

During Stage 2, different doses of the individual study drugs will be tested based on the highest tolerable combination dose that was found in Stage 1.

Study Drug Administration:

During each 3-week "study cycle," you will take sunitinib 1 time each day (either with or without food) for 2 weeks followed by 1 week of rest with no study drug.

You will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30 minutes before you receive temsirolimus, you will receive Benadryl (diphenhydramine) by vein over 30 minutes to help prevent side effects.

If you have any side effects from any of the drugs, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

Study Visits:

Every week (right before you receive temsirolimus), blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of every cycle:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any drugs or treatments you may be receiving.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests (in addition to the weekly blood draw described above).

On Day 1 of Cycle 3:

Blood (about 2 teaspoons) will be drawn to check your thyroid function. Urine will be collected for routine tests.

Every 6 weeks, you will have the same imaging scans (CT and/or MRI scan) that you had at the screening visit.

Blood Pressure Monitoring:

During the first 4 weeks of the study, your blood pressure will be checked weekly. This may be done at your local doctor's office. You should write down your blood pressure each time it is checked in a blood pressure journal that the study staff will give you and bring it with you when you see your doctor.

Length of Study:

You will remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or if you have intolerable side effects.

End-of-Study Visit:

After the last dose of study drug, you will have an end-of-study visit. At the end-of-study visit, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any drugs or treatments you may be receiving.

- You will be asked about any side effects you may have experienced since your last visit.

This is an investigational study. Sunitinib and temsirolimus are both FDA approved and commercially available for the treatment of advanced kidney cancer. The use of the drugs in combination is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M.D. Anderson.

Study Design

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

Conditions

Renal Cell Cancer

Intervention

Sunitinib, Temsirolimus

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:45-0400

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Persistent high BLOOD PRESSURE due to KIDNEY DISEASES, such as those involving the renal parenchyma, the renal vasculature, or tumors that secrete RENIN.

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