drugset / Trial / NCT01235793

The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma

NCT01235793 ↗

Phase 2 Terminated 11 enrolled Cedars-Sinai Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of the study will be testing the dosing of temozolomide to find the target dose that a person can tolerate. The other part of the study will be determining how helpful it can be to CNS lymphoma patients by adding temozolomide to the "conditioning regimen" prior to stem cell transplantation. This research study is designed to test the investigational use of temozolomide as part of a conditioning regimen prior to stem cell transplantation. This drug has not yet been approved by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell transplantation in lymphomas of the brain (central nervous system or CNS) but it has been studied and used before in transplantation with reasonable results.

Timeline

Start
2010-10-14
Primary completion
2017-07-28
Completion
2018-04-18

Outcome

Outcome not reported

Stopped (Enrollment): “The clinical trial was terminated due to poor enrollment”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 250 mg/m2 Oral