TPI 287 in Patients With Recurrent Glioblastoma Multiforme

Brain Cancer Clinical Trial

Official title: A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Brain Cancer
• Glioblastoma

• NCT number: NCT01113463
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: April 2010
• Completion date: December 2012