Actively Recruiting
Phase I-II Study Evaluating HSV-tk Gene Therapy With Valacyclovir, Radiotherapy, and Chemotherapy for Recurrent Glioblastoma Multiforme
Led by David Baskin MD · Updated on 2026-03-30
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
David Baskin MD
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of a combination treatment involving HSV-tk gene therapy, valacyclovir, radiotherapy, and chemotherapy for patients with recurrent glioblastoma multiforme or anaplastic astrocytoma who have not responded to standard treatments. This phase I-II study focuses on patients who previously underwent surgery and chemoradiation but experienced tumor recurrence. The study aims to evaluate the treatment’s impact on tumor progression, neurological function, and overall survival. During the study, the gene therapy HSV-tk is injected directly into the tumor during surgery. Within 24 hours, participants begin taking valacyclovir for 14 days. Radiotherapy is delivered in 10 sessions over two weeks, starting within nine days after surgery. Chemotherapy, which follows standard care, is given concurrently with or after radiotherapy based on clinical judgment. Patients may receive a second HSV-tk treatment six months after the first if appropriate. Participants will undergo neurological exams, cognitive testing, imaging studies, and blood tests to monitor immune response, blood counts, and liver function. Researchers will assess side effects using standard toxicity grading scales and observe median time to tumor progression and survival time, with follow-up lasting up to five years. The study includes ongoing assessments every 6 to 14 weeks to monitor disease status and patient health.
CONDITIONS
Brief Title
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven recurrent anaplastic astrocytoma or glioblastoma multiforme without multifocal tumor or brainstem involvement
- Radiographic evidence of tumor recurrence/progression
- At least 3 weeks since last major surgery, radiotherapy, or systemic anticancer therapy
- Life expectancy of 12 weeks or more
- ECOG performance status of 0-1
- Prior surgery and radiotherapy/chemotherapy for glioblastoma
- Patients with leptomeningeal disease may be eligible
- No evidence of other active cancers except certain skin cancers
- 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 baseline organ function, including specific lab value requirements
- Non-English speaking patients can participate
You will not qualify if you...
- Prior immunomodulatory therapy, immunotherapy, or gene vector therapy within 3 months
- Any chemotherapy, radiotherapy, immunotherapy, or investigational drug within 3 weeks before study treatment
- Evidence of multifocal disease or brainstem involvement
- Use of immunosuppressive drugs other than steroids for brain edema
- Diffuse or spinal spread of leptomeningeal disease
- Bulky leptomeningeal metastases that could obstruct cerebrospinal fluid flow
- Liver disease such as cirrhosis or active hepatitis B or C
- Alcohol misuse or abuse within the past 12 months
- Known allergy to HSV-tk gene vector or valacyclovir
- Inability to swallow oral medications
- Active cancers other than specific skin or treated cancers with long remission
- Pregnant or breastfeeding women or those unwilling to use birth control
- Active or suspected uncontrolled infection or immunocompromise including positive HIV
- Age under 18 years
- Inability or unwillingness to comply with study protocol
- Active CNS toxoplasmosis or progressive multifocal leukoencephalopathy
- Untreated cellulitis or wound infections
- Active intravenous drug or severe opioid abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery where the HSV-tk gene therapy is injected at the tumor site.
1 visit (in-person surgery)
Duration - Approximately 6 weeks depending on chemotherapy duration
Participants receive valacyclovir for 14 days, radiotherapy over 10 sessions within 2 weeks starting within 9 days after surgery, and chemotherapy started concurrent with or after radiotherapy based on clinical judgment.
Approximately 10 radiotherapy sessions and chemotherapy visits as per routine care
Duration - Up to 60 months
Participants are monitored for disease progression and survival with assessments every 6-8 weeks during the first year, then every 12-14 weeks thereafter until progression or death.
Regular visits every 6-8 weeks for 1 year, then every 12-14 weeks
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
H
Helga M Jones
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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