NCT03603405

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Glioblastoma
• Anaplastic Astrocytoma

Interventions

Type	Name	Description
DRUG	ADV/HSV-tk (gene therapy)	The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy

Timeline

• Start date: 2018-02-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2018-07-27
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study