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.

Condition	Treatment or Intervention	Phase
childhood brain tumor childhood meningioma childhood spinal cord tumors Neuroblastoma	Drug: temozolomide  Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both

Criteria

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

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Mark William Kieran, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000396780; DFCI-01279; NCT00098865
Record last reviewed:  November 2004
Last Updated:  February 4, 2005
Record first received:  December 8, 2004
ClinicalTrials.gov Identifier:  NCT00098865
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08