Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy

Investigator: David Baskin, MD

Study Coordinator: Larisse Yewah Gwei

Status: Open Not Enrolling

ClinicalTrials.gov Number: NCT03603405

Phone: 713.441.3834

Protocol Number: Pro00018178

Description

NCT03603405 This is a prospective, phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy and standard of care chemotherapy for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of newly diagnosed patients with AA or GBM. The intention is to treat all patients with the standard of care chemotherapy with temozolomide using the Stupp protocol and radiation therapy as well as with HSV-tk + valacyclovir gene therapy with a single dose administered intra-operatively at the time of tumor resection.
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