CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
temozolomide, thiotepa, carboplatin, 13-cis-retinoic aciddrug
Likely dose
Not stated in 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.

Search/NCT00528437
NCT00528437Phase 2Completed
CompareCT.gov

NYU 05-40 PBMTC ONC-032P:High Dose Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue (ASCR) Followed by Continuation Therapy With 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors

NYU Langone Health·interventional·Posted Sep 12, 2007·Updated Jul 8, 2021

In Brief

A Phase 2 clinical trial evaluating temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid for Brain Tumors. Completed, enrolled 46 participants across 17 sites in 2 countries.

Detailed Summary

The purpose of this study is to: Find out how safe and effective (by monitoring the good and/or bad effects) treatment with high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by 13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and proteins in the blood that break down the 13-cis-retinoic acid Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumors
CountriesCanada, United States
CollaboratorsChildren's Hospitals and Clinics of Minnesota, Schneider Children's Hospital

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2007
Enrollment StartOct 1, 2005
Primary CompletionJun 30, 2017
Study CompletionDec 30, 2017
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 18.8 years ago

Interventions

temozolomide, thiotepa, carboplatin, 13-cis-retinoic aciddrug

13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.