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Sponsors and Collaborators: |
Stanford University Cephalon Cell Therapeutics |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00185861 |
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.
Condition | Intervention | Phase |
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Brain Cancer |
Drug: Arsenic Trioxide Procedure: Stereotactic radiosurgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma |
Estimated Enrollment: | 12 |
Study Start Date: | December 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Evidence of recurrent disease.
Patients must have normal organ and marrow functions as defined below:
electrocardiogram with a rate corrected QT interval (QTc) <500 msec
*Oral or intravenous supplementation may be used to normalize serum electrolytes
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Iris Catrice Gibbs | Stanford University |
Study ID Numbers: | BRNCNS0001, 79756, BRNCNS0001, NCT00185861 |
Study First Received: | September 12, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00185861 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Arsenic trioxide Neuroepithelioma Central Nervous System Diseases |
Central Nervous System Neoplasms Glioma Brain Diseases Nervous System Neoplasms Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial Pharmacologic Actions |