OncoMatch/Clinical Trials/NCT03603405

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Is NCT03603405 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies ADV/HSV-tk (gene therapy) for glioblastoma.

Phase 1/2RecruitingThe Methodist Hospital Research InstituteNCT03603405Data 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 newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

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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

No prior treatment (treatment-naive required)

Max 0 prior lines

Must have received: surgery

prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor

Cannot have received: immunomodulatory therapy

Exception: within past 3 months

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

Cannot have received: immunotherapy

Exception: within past 3 months

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

Cannot have received: gene vector therapy

Exception: within past 3 months

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

Cannot have received: cytotoxic chemotherapy

Exception: within 3 weeks of study treatment start

Any cytotoxic chemotherapy ... within 3 weeks of study treatment start.

Cannot have received: radiation therapy

Exception: within 3 weeks of study treatment start

Any ... RT ... within 3 weeks of study treatment start.

Cannot have received: immunotherapy

Exception: within 3 weeks of study treatment start

Any ... immunotherapy ... within 3 weeks of study treatment start.

Cannot have received: investigational drug

Exception: within 3 weeks of study treatment start

Any ... investigational drug within 3 weeks of study treatment start.

Lab requirements

Blood counts

platelet count > 100,000/ml , anc> 1500/ml , hgb> 10 gm/dl

Kidney function

serum creatinine < 1.5 mg/dl

Liver function

t. bilirubin < 2.5 mg/dl, alt, ast, ggt and alk phos < 2 x normal

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 NCT03603405 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

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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Glioblastoma trials