Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma
|ClinicalTrials.gov Identifier: NCT00826241|
Recruitment Status : Unknown
Verified March 2015 by National Institutes of Health Clinical Center (CC).
Recruitment status was: Active, not recruiting
First Posted : January 22, 2009
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Spinal Cord Tumors||Drug: Temozolomide Drug: Lapatinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2017|
Experimental: Temozolomide + Lapatinib
Temozolomide starting dose 125 mg/m2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.
Starting dose 125 mg/m2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.
Other Name: TemodarDrug: Lapatinib
Starting dose 1250 mg daily by mouth.
Other Name: GW572016
- Time to Progression [ Time Frame: Assessed every two months till disease progression ]Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death.
- Anti-Tumor Activity [ Time Frame: 4 weeks ]Anti-tumor activity determined by the overall response complete response of partial response (CR or PR) rate. MacDonald criteria used to determine overall response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826241
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center - Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Marta Penas-Prado, MD||M.D. Anderson Cancer Center|