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Clinical Trial Summary

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.


Clinical Trial Description

This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy in recurrent glioblastoma multiforme or anaplastic astrocytoma. This study is comprised of patients who have failed standard of care treatment (maximal safe resection followed by chemoradiation). Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination wherever a re-operation is clinically indicated. Blood samples will be taken for systemic immunological response, blood counts and liver functions tests. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores. Patients will also be followed to assess median time to progression and median survival. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03596086
Study type Interventional
Source The Methodist Hospital Research Institute
Contact David S Baskin, MD
Phone 713-441-3803 or 713-201-5792
Email DBaskin@houstonmethodist.org
Status Recruiting
Phase Phase 1/Phase 2
Start date December 11, 2017
Completion date December 30, 2025

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