Thalidomide and Temozolomide in Treating Young Patients With Relapsed or Progressive Brain Tumors or Recurrent 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.
Brain and Central Nervous System Tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma|
- Feasibility at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Evidence of biologic activity as measured by radiographic response at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Toxicity as assessed by CTC 2.0 during treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Radiographic techniques as markers of tumor response as assessed by perfusion and diffusion MRI at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- In vitro correlative studies as markers of tumor response as assessed by urine and blood angiogenesis marker evaluation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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 unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098865
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Mark W. Kieran, MD, PhD||Dana-Farber Cancer Institute|