Expired Study
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Boston, Massachusetts 02115


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.

Study summary:

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.


DISEASE CHARACTERISTICS: - Histologically confirmed* diagnosis of 1 of the following: - Poor prognosis brain tumor - Relapsed or progressive disease - No curative therapy exists - Neuroblastoma - Recurrent disease NOTE: *Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease - Patients with brain stem glioma must have symptoms lasting < 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Karnofsky 50-100% OR - Lansky 50-100% Life expectancy - More than 2 months Hematopoietic - Hemoglobin ≥ 9.0 g/dL - Platelet count > 75,000/mm^3 - WBC > 2,000/mm^3 - Absolute neutrophil count > 1,000/mm^3 Hepatic - Bilirubin ≤ 1.5 mg/dL - SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac) - Alkaline phosphatase ≤ 2 times normal - No active hepatic disease ≥ grade 3 Renal - Creatinine < 1.5 mg/dL OR - Creatinine clearance ≥ 70 mL/min - No active renal disease ≥ grade 3 Cardiovascular - No active cardiac disease ≥ grade 3 Pulmonary - No active pulmonary disease ≥ grade 3 Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.^®) program - No active psychiatric disease ≥ grade 3 PRIOR CONCURRENT THERAPY: Biologic therapy - Prior biologic therapy allowed - No prior thalidomide Chemotherapy - Prior chemotherapy allowed - No prior temozolomide Endocrine therapy - Concurrent steroids allowed Radiotherapy - Prior radiotherapy allowed Surgery - Prior surgery allowed Other - Concurrent antiseizure medications allowed - No other concurrent investigational agents



Primary Contact:

Study Chair
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute

Backup Contact:


Location Contact:

Boston, Massachusetts 02115
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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