Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT03596086

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Led by David Baskin MD · Updated on 2026-03-30

62

Participants Needed

1

Research Sites

472 weeks

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

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.

CONDITIONS

Official Title

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without multifocal tumor or brainstem involvement
  • Radiographic evidence of recurrence or progression by iRANO criteria
  • At least 3 weeks since major surgery, radiotherapy, or systemic anticancer therapy with recovery from acute toxicities
  • Life expectancy of at least 12 weeks
  • Can receive a second HSV-tk treatment after 6 months if applicable
  • ECOG performance status of 0-1
  • Prior surgery and radiotherapy/chemotherapy for glioblastoma
  • Patients with leptomeningeal disease may be considered
  • No active malignancy except certain skin cancers
  • Signed informed consent
  • Willing to provide biopsies as required
  • Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days before first treatment and not be lactating
  • WOCBP and men must use effective birth control
  • Adequate baseline organ function based on laboratory tests
  • Non-English speaking patients may participate
Not Eligible

You will not qualify if you...

  • Prior immunomodulatory therapy, immunotherapy, or gene vector therapy within 3 months
  • Cytotoxic chemotherapy, radiotherapy, immunotherapy, or investigational drugs within 3 weeks of treatment start
  • Evidence of multifocal disease or brainstem involvement
  • Use of immunosuppressive drugs except steroids for brain edema
  • In leptomeningeal disease, diffuse disease or spinal spread or bulky metastases obstructing CSF flow
  • Liver disease such as cirrhosis or active/chronic hepatitis B or C
  • Alcohol misuse or abuse within past 12 months
  • Known allergy or hypersensitivity to gene therapy components or valacyclovir
  • Inability to swallow oral medications
  • Active malignancy except certain skin or treated cancers disease free >5 years
  • Pregnant or breastfeeding women or unwilling to use effective birth control
  • Active or uncontrolled infection or immunocompromise including positive HIV
  • Under 18 years of age
  • Unable or unwilling to follow study protocol
  • Active CNS toxoplasmosis or progressive multifocal leukoencephalopathy
  • Active 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

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Trial Site Locations

Total: 1 location

1

Houston Methodist Neurological Institute

Houston, Texas, United States, 77030

Actively Recruiting

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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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