Phase I Dose Escalation Study of Temozolomide With Autologous Stem Cell Rescue for Patients With Relapsed/Refractory CNS Malignancy Including Isolated Metastatic Disease
High dose chemotherapy and autologous stem cell transplant is an accepted treatment
alternative for patients with brain tumors. Temozolomide has been approved for use by the
United States Food and Drug Administration (FDA) for certain tumors of the brain. The doses
of temozolomide given in this study will be higher than approved by the FDA and higher than
those given in any prior studies.
Over 25 subjects will be enrolled on this study over a period of 5 years. This study will
only be available at Tufts Medical Center.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of temozolomide with hematopoietic stem cell rescue in patients with recurrent CNS malignancy
5 years
Yes
Andreas Klein, MD
Principal Investigator
Tufts Medical Center
United States: Institutional Review Board
CN-306
NCT00629187
April 2004
April 2012
Name | Location |
---|---|
Tufts Medical Center | Boston, Massachusetts 02111 |