- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00095771
Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Kenneth J. Cohen, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Antineoplastic Agents
- Arsenic Trioxide
Other Study ID Numbers
- CDR0000393829
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-J0423
- JHOC-04041906
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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