HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Status Recruiting

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

Clinical Trial Details

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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