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.
Drug: Arsenic Trioxide
Procedure: Stereotactic radiosurgery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma|
- Describe and define toxicities of ATO combined with radiotherapy in patients with recurrent malignant glioma.
- Define the maximum tolerated dose (MTD) of ATO combined with stereotactic radiotherapy for recurrent malignant glioma.
- Evaluate time to progression and survival
- Evaluate radiographic tumor response rate
- Determine the recommended dose for investigation in a Phase II study
|Study Start Date:||December 2003|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Iris Catrice Gibbs||Stanford University|