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Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
Not Recruiting
Trial ID: NCT00095771
Purpose
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 damage tumor cells and may be an effective treatment for patients with
glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to
radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with
radiation therapy in treating patients who have newly diagnosed gliomas.
Official Title
A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood
Stanford Investigator(s)
Paul Graham Fisher, MD
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Iris C. Gibbs, MD, FACR, FASTRO
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Eligibility
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
Intervention(s):
radiation: radiation therapy
drug: arsenic trioxide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535