A Phase II Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain
The Study Drug:
TPI-287 is designed to prevent cancer cells from dividing, which may slow and/or stop the
growth of cancer cell.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive, TPI 287 by
vein over 60 minutes on Day 1 of every 21 day cycle.
Before you receive the study drug, you will receive dexamethasone by mouth, Benadryl
(diphenhydramine HCL) by vein over 30-60 minutes, and ranitidine over 30-60 minutes to help
prevent a potential serious allergic reaction.
At all study visits, you will be asked about any side effects you may be having and about
any other drugs you may be taking.
On Days 1, 8, and 15 of Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine
tests. If you are taking coumadin, blood (about 1-2 teaspoons) will be drawn to check how
well your blood clots.
On Day 1 of Cycle 1, your performance status will be recorded and your vital signs will be
Within 7 days of Day 1 of Cycles 2 and beyond:
- Blood (about 2-3 tablespoons) will be drawn for routine tests. If you are taking
coumadin, blood (about 1-2 teaspoons) will be drawn to check how well your blood clots.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will have a neurological exam.
Every 6 weeks (that is, before each odd-numbered cycle):
- You may have CT scans or MRI scans of the chest, abdomen, and pelvis to check the
status of the disease.
- You will have a MRI of your brain. The MRI will require a catheter to be inserted into
one of your veins in order to inject the MRI contrast agent.
The study doctor and staff will review your imaging scans to check what stage of disease the
tumors inside and/or outside your brain are.
Length of Study:
You may continue to receive TPI 287 for as long as the doctor thinks it is in your best
interest. You will no longer be able to receive TPI 287 if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after you have completed the end-of-treatment
and follow-up visits.
End-of Treatment Visit:
About 4 weeks after you stop taking TPI 287:
- You will have a physical exam, including measurement of your vital signs.
- You will have a neurological exam.
- Your performance status will be measured.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a CT and/or MRI to check the status of the disease. This may include a
brain MRI. If your doctor thinks it is needed, you will have a bone scan.
- You will be asked about any side effects you may have had any drugs you may be taking.
Once you are off-study, you will be contacted either in the clinic or by phone every 3
months for up to 1 year after you enrolled on the study to check on the status of your
health. If you are called, it will take less than 5 minutes.
This is an investigational study. TPI 287 is not FDA approved or commercially available.
At this time, TPI 287 is being used in research only.
Up to 69 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Overall response rate [ORR = Complete Responses plus Partial Responses (CR + PR)] where response rates for brain metastases evaluated by MacDonald criteria, and for extracranial disease by standard RECIST, through a combination of radiologic scans and neurological examination and MRI brain scans.
Nuhad K. Ibrahim, MD,BS
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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