Status:
COMPLETED
Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-21 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to dama...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of arsenic trioxide when administered with radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Clinical and neuroradiographic findings consistent with intrinsic pontine glioma
- Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma
- Multifocal high-grade gliomas allowed
- No exophytic tumors
- No focal lesions
- No underlying diagnosis of neurofibromatosis
- No tumors originating in anatomic structures adjacent to the cerebellar peduncle or cervical medullary junction
- PATIENT CHARACTERISTICS:
- Age
- 3 to 21
- Performance status
- Karnofsky 60-100% OR
- Lansky 60-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Hemoglobin \> 10 g/dL
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 2.0 mg/dL
- Alkaline phosphatase \< 2.5 times upper limit of normal (ULN)
- Transaminases \< 2.5 times ULN
- Renal
- Creatinine \< 2.0 times ULN
- Cardiovascular
- No second-degree heart block
- No absolute QTc interval \> 500 msec with normal potassium and magnesium levels
- Other
- Not pregnant or nursing
- Negative pregnancy test
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
- No other serious medical illness
- Able to undergo MRI
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 28 days since prior biologic therapy
- No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
- Chemotherapy
- No prior arsenic trioxide
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Prior surgery for the brain tumor allowed
- Other
- No other prior therapy for the brain tumor
- More than 28 days since prior investigational drugs or devices
- No concurrent amphotericin B
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00095771
Start Date
November 1 2004
End Date
January 1 2011
Last Update
April 22 2011
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410