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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 9, 2004
Last Update Posted: April 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

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.

Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: arsenic trioxide Radiation: radiation therapy Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion
  • Safety as assessed by NCI CTCAE v. 3.0 following study completion

Estimated Enrollment: 36
Study Start Date: November 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the maximum tolerated dose of arsenic trioxide when administered with radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).

Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ATO until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36 months.


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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 3 to 21

Performance status

  • Karnofsky 60-100% OR
  • Lansky 60-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin > 10 g/dL
  • Platelet count > 100,000/mm^3


  • Bilirubin < 2.0 mg/dL
  • Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
  • Transaminases < 2.5 times ULN


  • Creatinine < 2.0 times ULN


  • No second-degree heart block
  • No absolute QTc interval > 500 msec with normal potassium and magnesium levels


  • 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


Biologic therapy

  • More than 28 days since prior biologic therapy
  • No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])


  • No prior arsenic trioxide

Endocrine therapy

  • Not specified


  • Not specified


  • Prior surgery for the brain tumor allowed


  • No other prior therapy for the brain tumor
  • More than 28 days since prior investigational drugs or devices
  • No concurrent amphotericin B
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095771

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Kenneth J. Cohen, MD, MBA Sidney Kimmel Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00095771     History of Changes
Other Study ID Numbers: CDR0000393829
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Last Update Posted: April 22, 2011
Last Verified: April 2011

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
untreated childhood brain stem glioma
childhood high-grade cerebral astrocytoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Arsenic trioxide
Antineoplastic Agents