Clinical Trial Details
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NCT01189266 : Vorinostat and Radiation Therapy Followed By Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Pontine Glioma
PhasePhase 1/Phase 2
AgesMin: 3 Years Max: 21 Years
Inclusion Criteria:

- Newly diagnosed diffuse intrinsic pontine gliomas (defined as tumors with a pontine
epicenter and diffuse involvement of ? 2/3 of the pons)

- Patients with brainstem tumors that do not meet these criteria or are not
considered to be typical intrinsic pontine gliomas are eligible provided their
tumors are biopsied and proven to be an anaplastic astrocytoma, glioblastoma
multiforme, gliosarcoma, or anaplastic mixed glioma

- No patients with juvenile pilocytic astrocytoma, fibrillary astrocytoma,
gangliogliomas, or other mixed gliomas without anaplasia

- No patients with disseminated disease (MRI of the spine must be performed if
disseminated disease is suspected by the treating physician)

- Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky
PS 50-100% (for patients ? 16 years of age)

- Patients who are unable to walk because of paralysis, but who are up in a
wheelchair, will be considered ambulatory for the purpose of assessing the
performance status

- ANC ? 1,000/uL

- Platelet count ? 100,000/uL (transfusion independent, defined as not receiving
platelet transfusions within the past 7 days)

- Hemoglobin ? 8.0 g/dL (RBC transfusions allowed)

- Creatinine clearance or radioisotope GFR ? 70 mL/min OR a serum creatinine based on
age/gender as follows:

- ? 0.8 mg/dL (for patients 3 to < 6 years of age)

- ? 1 mg/dL (for patients 6 to < 10 years of age)

- ? 1.2 mg/dL (for patients 10 to < 13 years of age)

- ? 1.4 mg/dL (for female patients ? 13 years of age)

- ? 1.5 mg/dL (for male patients 13 to < 16 years of age)

- ? 1.7 mg/dL (for male patients ? 16 years of age)

- Bilirubin (sum of conjugated + unconjugated) ? 1.5 times upper limit of normal (ULN)
for age

- ALT ? 110 U/L (for the purpose of this study, the ULN for ALT is 45 U/L)

- Serum albumin ? 2 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow capsules or liquids

- Not dependent on NG tube feeding

- Patients with seizure disorder are eligible provided that they are not on
enzyme-inducing anticonvulsants and seizures are well controlled

- No uncontrolled infection

- No patients who, in the opinion of the investigator, may not be able to comply with
the safety monitoring requirements of the study

- No prior treatment except for dexamethasone and/or surgery

- At least 2 weeks since prior valproic acid

- More than 7 days since prior growth factors that support platelet or white cell
number or function

- No other concurrent investigational drugs

- No other concurrent anticancer agents (including chemotherapy, immunotherapy, or
biologic therapy)

- No concurrent coumadin, heparin, low-molecular weight heparin, or any other

- No concurrent aspirin (> 81 mg/day), NSAIDs, clopidogrel (Plavix), dipyridamole
(Persantine), or any other drug that inhibits platelet function

- No concurrent enzyme-inducing anticonvulsants
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