Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma
To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I dose escalation trial. Results from this study will provide a basis for further study of ATO combined with radiation therapy as a radiosensitizer for malignant brain tumors in future Phase II studies.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Paul Graham Fisher, MD
- Iris C. Gibbs, MD, FACR
- Lawrence Recht, MD
- Huy M. Do, MD
- Susan Knox
- Griffith Harsh, MD
- drug : Arsenic Trioxide
- procedure : Stereotactic radiosurgery
Phase: Phase 1
Ages Eligible For Study:
- Evidence of recurrent disease. - All patients will have received previous conventional radiotherapy at least 3 weeks prior to enrollment. Histologic verification of malignant glioma is required. If the initial primary brain tumor was histologically malignant glioma and subsequent contrast enhanced MRI imaging shows tumor consistent with recurrence, additional biopsy or surgery is not required. However, if a low-grade neoplasm was the initial histologic diagnosis, tissue confirmation of malignant glioma is required at the time of recurrence. - Age: Patients must be >18 years of age - Patients must have a Karnofsky >60%, and/or ECOG performance status <2 - Patients must have an estimated life expectancy of greater than 8 weeks. - Patients must have normal organ and marrow functions as defined below: - Leukocytes >3,000/¼l - Absolute neutrophil count >1,500/¼l - Hemoglobin > 10 gm/dl - Platelets >100,000/¼l (transfusion independent) - Total bilirubin within normal institutional limits - AST (SGOT)/ALT (SGPT) <1.5 X institutional upper limit of normal - Creatinine within normal institutional limits OR - Creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Serum potassium* e 4.0mEq/L - Serum magnesium* e 1.8mEq/L - Serum calcium* within the institutional normal range (should be corrected if low normal) - Electrocardiogram Normal - electrocardiogram with a rate corrected QT interval (QTc) <500 msec *Oral or intravenous supplementation may be used to normalize serum electrolytes - Phase I ATO Stereotactic Radiotherapy for Recurrent Malignant Glioma 16 of 44 - Informed consent All patients or their legal guardians must sign a document of informed consent indicating their understanding of the investigational nature of this study and the risks involved prior to any protocol related are performed (which does not include imaging and laboratory studies that help to establish eligibility).