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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00095771
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kenneth J. Cohen, MD, MBA
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410

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