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TPI 287 in Patients With Recurrent Glioblastoma Multiforme

2014-08-27 03:14:05 | BioPortfolio

Summary

The goal of this clinical research study is to learn if TPI 287 can help to control glioblastoma. The safety of this drug will also be studied.

Description

The Study Drugs:

TPI 287 is designed to block a protein that causes cancer cells to resist the effects of chemotherapy. By blocking the protein, the drug may be able to cause the cancer cells to shrink or stop growing.

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 you have had some of these tests recently, they may not need to be repeated.

Within 28 days before you can be enrolled on the study, you will have a magnetic resonance imaging (MRI) scan to check the status of the disease.

Within 14 days before you can be enrolled on the study:

- Blood (about 1 tablespoon) will be drawn for routine tests.

- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) or urine pregnancy test.

Within 7 days before you can be enrolled on the study:

- Your medical history will be recorded.

- You will be asked about any drugs you may be taking and if you have experienced any side effects.

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

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

- You will have a neurological exam. The neurological exam is performed with a series of questions and tests which should take about 20 minutes to complete. You will be asked how well you are able to perform tasks that test the part of your brain you use to remember, communicate, and follow simple commands.

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 treatment options will be discussed with you.

Study Drug Administration:

On Day 1 of each 21-day study "cycle," you will receive TPI 287 by vein over about 1 hour.

If you experience intolerable side effects, the dose of TPI 287 may be lowered. Your doctor will tell you more about lowering a dose due to side effects.

To help prevent an allergic reaction to TPI 287, you will also receive the following drugs:

- Benadryl® (diphenhydramine) by vein over 30 minutes, 30-60 minutes before you receive TPI 287

- Cimetidine by vein over 30 minutes, 30-60 minutes before you receive TPI 287

- Either dexamethasone or methylprednisolone (taken by mouth 12 and 6 hours before you receive TPI 287; or by vein over 30 minutes at about 30-60 minutes before you receive TPI 287)

Study Visits:

At each study visit, you will be asked about any drugs you may be taking and about any side effects you may have experienced.

On Day 1 of Cycle 1:

- Your weight and vital signs will be measured.

- If your doctor thinks it is needed, blood (about 1 tablespoon) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond:

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

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests

On Day 15 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have an MRI scan to check the status of the disease.

Length of Study:

You will be on study for up to 6 months. You may continue to receive the study drug for as long as you are benefiting. You will be taken off study if the disease gets worse or if you experience intolerable side effects.

End-of-Treatment Visit:

Within 28 days after you stop receiving the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:

- You will be asked about any drugs you may be taking and if you have experienced any side effects.

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

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will have an MRI scan to check the status of the disease if you did not have one within 6 weeks before the end-of-treatment visit.

Long-Term Follow-Up:

Every 3 months for up to 1 year after you stop receiving the study drug, you will be called and asked about how you are feeling. Each phone call will last about 5-10 minutes.

This is an investigational study. TPI 287 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 50 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

Brain Cancer

Intervention

TPI 287

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: 2014-08-27T03:14:05-0400

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