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HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Glioblastoma Clinical Trial

Official title:
Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination With Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.

Clinical Trial Summary

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

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 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. Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination. Blood samples will be taken for systemic immunological response, blood counts, and liver functions tests. Genetic testing of tumor tissue will be performed, including genetic analysis and cell cultures. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores (see Appendices). 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 NCT03603405
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 February 28, 2018
Completion date December 31, 2025
View Details
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