HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Baskin MD
About this trial
Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.
Eligibility criteria
Qualifiers
All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement. Multifocal disease does not exist if enhancing areas are connected by abnormal T2 FLAIR on the MRI scan.
Radiographic evidence of recurrence/progression by iRANO criteria
≥ 3 weeks since any major surgery, completion of RT, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).
Life expectancy ≥ 12 weeks.
Disqualifiers
Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.
Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start.
Evidence of multifocal disease, brainstem involvement
Patients on immunosuppressive drugs (other than steroids for brain edema).
Trial design
Treatments tested in this trial
- ADV/HSV-tk (gene therapy)
Treatment groups
62 Participants
are divided into 1 treatment groupSponsors and collaborators
David Baskin MD
Lead sponsor
The Methodist Hospital Research Institute
Sponsor institution
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator
The Methodist Hospital Research Institute
Collaborator
Source ClinicalTrials.gov