Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

Completed · Phase 1

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

In brief

This phase I trial is studying the side effects and best dose of arsenic trioxide and radiation therapy in treating patients with newly diagnosed malignant glioma. Drugs such as arsenic trioxide may stop the growth of malignant glioma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining arsenic trioxide with radiation therapy may kill more tumor cells.

Key facts

Study ID: NCT00045565
Run by: National Cancer Institute (NCI)
People needed: 30
Starts: 2002-10-01
Last updated by the study team: 2013-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
Absolute neutrophil count 1500/mm\^3
Platelets 100,000/mm\^3
Creatinine =< 1.5 mg/dL
Total bilirubin < 2 mg/dl
Transaminases < 4 times above the upper limits of the institutional normal
Serum potassium > 3.0 and < 5.5mEq/l
Magnesium > 1.2 and < 2.5 mEq/l
Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits
Patients must not be pregnant or breast-feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception; patients who are pregnant or breast-feeding will be excluded because no information on this agent exists with regard to safety for a fetus or breast-feeding infant
Patients must have a Karnofsky performance status of >= 60%
No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the therapy outlined in this protocol with reasonable safety
Patients must have a mini mental score >= 15

You may not qualify if…

Patients with a prior malignancy; patients with curatively treated carcinoma in situ or basal cell carcinoma of the skin or patients who have been free of disease for >= five years are eligible for this study
Patients who are pregnant or breast-feeding; these patients are excluded because no information on this agent exists with regard to safety for a fetus or breast-feeding infant
Prior therapy (surgery excluded) for the brain tumor
Patients with second-degree heart block
Patients who are being treated with Amphotericin B
Patients who cannot undergo MRI are not eligible for this study
Patients who are currently taking drugs that are known to prolong the QT interval; in order to be eligible patients will need to be off these drugs for >= 5 days prior to starting treatment; patients may not resume these drugs for > 2 weeks after last ATO treatment; if QT prolongation continues after 5 days post drug discontinuation, the patient is not eligible for ATO treatment

Where it is running

New Approaches to Brain Tumor Therapy Consortium — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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