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.

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.
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.

Temozolomide + Lapatinib

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

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).

Time to Progression

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 an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria

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.

Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Overall Study

Dr. Mark Gilbert

Brain Tumors

Spinal Cord Tumors

Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.

Temozolomide

Lapatinib

The University of Texas M.D.Anderson Cancer Center

University of California, San Francisco

Dana Farber Cancer Institute

Memorial Sloan Kettering Cancer Center

University of Pittsburgh Medical Center - Hillman Cancer Center

University of Texas MD Anderson Cancer Center

University of Wisconsin School of Medicine and Public Health

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma

ependymoma/qusma

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

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