Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma
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|ClinicalTrials.gov Identifier: NCT00826241|
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Spinal Cord Tumors||Drug: Temozolomide Drug: Lapatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 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|
|Actual Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Experimental: Temozolomide + Lapatinib
Temozolomide starting dose 125 mg/m^2 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/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.
Other Name: Temodar
Starting dose 1250 mg daily by mouth.
Other Name: GW572016
- Time to Progression [ Time Frame: Assessed every two months till disease progression, up to 4 years ]Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
- Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria [ Time Frame: 4 weeks ]Anti-tumor activity as determined by the overall response (Complete response (CR) or partial response (PR)) was assessed by the MacDonald criteria. Complete response is complete resolution of all lesions. The patient cannot be on any corticosteroids with the exception of adrenal replacement doses. Partial response is ≥50% reduction in the sum of products of all measurable lesions over baseline sum observed using the same techniques as baseline. The patient must be on a stable or decreased dose of corticosteroids to be evaluable for response.
- Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [ Time Frame: Date treatment consent signed to date off study, approximately 111 months and 26 days ]Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|