TPI 287 in Breast Cancer Metastatic to the Brain
The goal of the first part of this clinical research study is to find the highest tolerable dose of TPI-287 in patients with breast cancer that has spread to the brain.
The goal of the second part of this study is to learn if TPI-287 can control breast cancer that has spread to the brain. The safety of this drug will also be studied.
Drug: TPI 287
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain|
- Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: TPI 287
TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Drug: TPI 287
Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle.
Starting Dose Phase II: Maximum tolerated dose from Phase I.
6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287.
Other Name: DecadronDrug: Benadryl
12.5-25 mg intravenous (IV) push 30-60 minutes prior
Other Name: DiphenhydramineDrug: Ranitidine
As H2 blocker 1mg/kg IV 30-60 minutes prior
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01332630
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nuhad K. Ibrahim, MD,BS||M.D. Anderson Cancer Center|