Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
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|ClinicalTrials.gov Identifier: NCT00095771|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : April 22, 2011
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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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: arsenic trioxide Radiation: radiation therapy||Phase 1|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
- 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
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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
- Karnofsky 60-100% OR
- Lansky 60-100%
- 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
PRIOR CONCURRENT 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
- 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
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|
|Study Chair:||Kenneth J. Cohen, MD, MBA||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
P30CA006973 ( U.S. NIH Grant/Contract )
|First Posted:||November 9, 2004 Key Record Dates|
|Last Update Posted:||April 22, 2011|
|Last Verified:||April 2011|
untreated childhood brain stem glioma
childhood high-grade cerebral astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases