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.
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
Andreas Klein, MD
Tufts Medical Center
United States: Institutional Review Board
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