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OncoMatch/Clinical Trials/NCT03596086

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

Is NCT03596086 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ADV/HSV-tk (gene therapy) for glioblastoma multiforme.

Phase 1/2RecruitingDavid Baskin MDNCT03596086Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Glioblastoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: surgery — for glioblastoma

has had prior surgery and radiotherapy /chemotherapy for the glioblastoma

Must have received: radiation therapy — for glioblastoma

has had prior surgery and radiotherapy /chemotherapy for the glioblastoma

Must have received: chemotherapy — for glioblastoma

has had prior surgery and radiotherapy /chemotherapy for the glioblastoma

Cannot have received: immunomodulatory therapy

Exception: allowed if >3 months prior

Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months

Cannot have received: immunotherapy

Exception: allowed if >3 months prior

Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months

Cannot have received: gene vector therapy

Exception: allowed if >3 months prior

Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months

Cannot have received: cytotoxic chemotherapy

Exception: allowed if >3 weeks prior

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start

Cannot have received: radiation therapy

Exception: allowed if >3 weeks prior

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start

Cannot have received: immunotherapy

Exception: allowed if >3 weeks prior

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start

Cannot have received: investigational drug

Exception: allowed if >3 weeks prior

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start

Lab requirements

Blood counts

Platelet count > 100,000/ml, ANC > 1500/ml, Hgb > 10 gm/dL, Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)

Kidney function

serum creatinine < 1.5 mg/dL

Liver function

T. bilirubin < 2.5 mg/dL, ALT, AST, GGT and AP < 2 x normal

serum creatinine < 1.5 mg/dL; T. bilirubin < 2.5 mg/dL, ALT, AST, GGT and AP < 2 x normal; Platelet count > 100,000/ml , ANC> 1500/ml , Hgb> 10 gm/dL; Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Houston Methodist Neurological Institute · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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