A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
- Determine the feasibility of thalidomide and temozolomide in pediatric patients with
relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.
- Determine, preliminarily, biologic activity of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive oral temozolomide on days 1-5 and oral thalidomide on days 1-28.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility at 6 months
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute
United States: Federal Government
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|