Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion
- measure
- Safety as assessed by NCI CTCAE v. 3.0 following study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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 BReferences
Publications (0)
Data not yet available