Status:
COMPLETED
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Boston Children's Hospital
Conditions:
Central Nervous System Tumor, Pediatric
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
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 dividin...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas. Secondary...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00098865
Start Date
September 1 2002
End Date
June 1 2010
Last Update
October 7 2014
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115