Neuroblastoma Clinical Trial
Official title:
A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the
tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
tumor cells from dividing so they stop growing or die. Combining thalidomide with
temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with
temozolomide in treating young patients who have relapsed or progressive brain tumors or
recurrent 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 evidence of biologic activity of this regimen in these
patients.
- Determine the toxic effects of this regimen in these patients.
STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who
can complete 6 months of therapy in the mixed population. With a target accrual of 20
patients the 90% confidence for the true feasibility rate will be no wider than 40%.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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