Clinical Trial Details
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NCT00514397 : Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
PhasePhase 2
AgesMin: 2 Years Max: 21 Years

Inclusion criteria:

- Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI

- No requirement for histological diagnosis

- Clinical history < 6 months

- Clinical findings must include at least 1 of the 3 following signs of brainstem

- Cranial nerve deficit

- Long tract signs

- Ataxia

Exclusion criteria:

- Focal lesions of brainstem

- Predominantly exophytic tumors


Inclusion criteria:

- Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in
status is a direct result of neurological involvement of the brainstem glioma)

- Life expectancy > 12 weeks

- Absolute neutrophil count ? 1,000/mm³

- Platelet count ? 100,000/mm³

- Hemoglobin ? 10 g/dL

- Urea and serum creatinine < 1.5 times upper limit of normal (ULN)

- Total and direct bilirubin < 1.5 times ULN

- AST and ALT < 3 times ULN

- Negative pregnancy test within 7 days prior to administration of temozolomide for
women of childbearing potential

Exclusion criteria:

- Frequent vomiting and/or medical condition, that could interfere with oral medication
intake (e.g., partial bowel obstruction)

- Pregnant or breast-feeding women


Exclusion criteria:

- Prior chemotherapy or radiotherapy

- Other concurrent investigational drugs

- Other concurrent chemotherapy, immunotherapy, or biologic therapy
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