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OncoMatch/Clinical Trials/NCT03596086

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

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

Phase 1/2RecruitingDavid Baskin MDNCT03596086Data as of Jun 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

Treatments studied

Other

ADV/HSV-tk (gene therapy)

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 →

Frequently asked questions

Is NCT03596086 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior immunomodulatory therapy, immunotherapy, gene vector therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Glioblastoma trials