At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
PPX +TMZ+XRTdrug
Likely dose
PPX +TMZ+XRT 50 mg/m2from 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.
BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.
In Brief
A Phase 2 clinical trial evaluating PPX +TMZ+XRT for Brain Tumor. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumor
CountriesUnited States
CollaboratorsRhode Island Hospital, MaineHealth
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartOct 2008
Primary CompletionJun 2011
Study CompletionJul 2012
TodayJul 2026
First PostedOct 1, 2008
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.8 years ago
Interventions
PPX +TMZ+XRTdrug
PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)