Trial Search Results

Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: arsenic trioxide
  • Radiation: radiation therapy

Phase:

Phase 1

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

Ages Eligible for Study

3 Years - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting