Clinical trial NCT01113463
Conditions: Brain Cancer
Keywords: Brain Tumor Central Nervous System CNS Glioblastoma Multiforme GBM TPI 287 Radiation Therapy Temozolomide Chemotherapy taxanes
Sponsor: M.D. Anderson Cancer Center
Start date: 2010-04-01; Completion date: 2012-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed 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.

Bevacizumab will be given to patients that are found to have brain damage, as described below. It is designed to block the growth of new blood vessels. It may help to lower the amount of brain damage related to tumor tissue death and help limit the symptoms of this condition.

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)

If you have an MRI scan that shows evidence of brain damage related to the tumor tissue death after you have received TPI 287 for two infusions, you will be eligible to receive bevacizumab. On Day 1 of Cycle 3 and beyond, if you are eligible, you will receive bevacizumab by vein over about 60-90 minutes.

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.

If you are eligible and you receive it, you may continue to receive bevacizumab for as long as you are benefiting. You will be taken off bevacizumab 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. Bevacizumab is FDA approved and commercially available for the treatment of brain tumors. The use of bevacizumab for brain damage related to the tumor tissue death is investigational.

Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: TPI 287 Starting dose 160 mg/m\^2 intravenous (IV) every 3 weeks
Interventions: intervention 1: TPI 287
Intervention descriptions: intervention 1: Starting dose of 160 mg/m\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).

Protocol documents: