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
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
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

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