Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma

Completed · Phase 1

Conditions studied: Brain Cancer

In brief

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.

Key facts

Study ID

NCT00185861

Run by

Stanford University

People needed

12

Starts

2003-12-01

Expected to finish

2009-04-01

Last updated by the study team

2009-04-09

Who can join

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

You may qualify if…

• 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).
• Exclusion Criteria:- Patients who have had chemotherapy or conventional radiotherapy within 3 weeks of enrollment.
• Patients who have received prior radiosurgery or stereotactic radiotherapy within 10mm of the current target tumor.
• Patients may not be receiving any other investigational agents.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.