Actively Recruiting
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Led by The Methodist Hospital Research Institute · Updated on 2026-03-30
62
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have biopsy-proven anaplastic astrocytoma or glioblastoma multiforme without multifocal disease or brainstem involvement
- Life expectancy of at least 12 weeks
- Newly diagnosed patients with no prior radiation or chemotherapy
- ECOG performance status of 0-1
- No other active cancers except certain skin cancers
- Patients with leptomeningeal disease may be eligible
- Signed informed consent obtained
- Willing to provide biopsies as required
- Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
- WOCBP and men must use effective birth control
- Adequate organ function with specified lab values
You will not qualify if you...
- Prior immunomodulatory therapy, immunotherapy, gene vector therapy, chemotherapy, radiotherapy, or investigational drug within specified recent timeframes
- Substantial multifocal disease or brainstem involvement
- Use of immunosuppressive drugs other than steroids for brain edema
- Active liver disease such as cirrhosis or hepatitis B/C
- Alcohol misuse or abuse within past 12 months
- Allergy or hypersensitivity to gene vector or valacyclovir
- Inability to swallow oral medications
- Active malignancy other than allowed skin or cervical cancers
- Active CNS toxoplasmosis or progressive multifocal leukoencephalopathy
- Active untreated infections or active IV or severe opioid drug abuse
- Pregnant or breastfeeding women or unwillingness to use birth control
- Active or uncontrolled infections or immunocompromise, including HIV
- Age under 18 years
- Unable or unwilling to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David S. Baskin, MD
CONTACT
H
Helga M. Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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