At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Temozolomide 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma
National Institutes of Health Clinical Center (CC)·interventional·Posted Jan 22, 2009·Updated Mar 22, 2019
In Brief
A Phase 2 clinical trial evaluating Temozolomide and Lapatinib for Brain Tumors and Spinal Cord Tumors. Completed, enrolled 58 participants across 6 sites.
Detailed Summary
The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumors, Spinal Cord Tumors
CountriesUnited States
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedJan 2009
Primary CompletionJul 2018
TodayJul 2026
First PostedJan 22, 2009
Enrollment StartJan 1, 2009
Primary CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 17.4 years ago
Interventions
Temozolomidedrug
Starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle.
Lapatinibdrug
Starting dose 1250 mg daily by mouth.