A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
OBJECTIVES:
Primary
- Determine the feasibility of thalidomide and temozolomide in pediatric patients with
relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.
Secondary
- 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
unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility at 6 months
6 months
Yes
Mark W. Kieran, MD, PhD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
01-279 DFCI
NCT00098865
September 2002
December 2010
Name | Location |
---|---|
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |