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Virus Therapy

Gene Therapy + Chemoradiotherapy for Glioblastoma

Phase 1 & 2

Recruiting

Led By David S. Baskin, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease or brainstem involvement

No evidence of other active malignancy except squamous or basal cell skin cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months measured in months

Awards & highlights

Study Summary

This trial is studying how well HSV-tk (gene therapy), valacyclovir, radiotherapy, and chemotherapy work in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma or anaplastic astrocytoma, confirmed by biopsy. Participants must have a life expectancy of at least 12 weeks, be able to provide biopsies, and not have multifocal disease or brainstem involvement. They should not be on immunosuppressive drugs (except steroids), have liver disease, alcohol misuse/abuse in the past year, known allergies to treatment components, trouble swallowing pills, other active malignancies (with exceptions), untreated infections or severe drug abuse.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of gene therapy using ADV/HSV-tk combined with valacyclovir medication, radiotherapy (XRT), and chemotherapy in patients who are newly diagnosed with glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).See study design

What are the potential side effects?

Potential side effects may include reactions related to gene therapy such as flu-like symptoms, headache and nausea; complications from taking valacyclovir like kidney issues; effects from radiotherapy including skin irritation and fatigue; plus typical chemotherapy side effects such as hair loss, nausea/vomiting and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy shows I have a specific brain tumor without it spreading in my brain.

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I have no active cancer except possibly skin cancer.

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I have been newly diagnosed with a high-grade brain tumor.

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I had surgery for a brain tumor and need another one for remaining cancer.

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I am fully active or can carry out light work.

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My organ functions are within normal ranges according to recent tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months measured in months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months measured in months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months measured in months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival in months up to 5 years from Study drug administration (Day 0)

Secondary outcome measures

Progression free survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: ADV/HSV-tk (gene therapy)Experimental Treatment1 Intervention

Experimental: ADV/HSV-tk (gene therapy) The gene therapy investigational product, HSV-tk will be injected during the surgery. Within 24 hours valacyclovir will be given for 14 days. Radiotherapy will be administered over 30 sessions (over 6 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent with the radiotherapy dependent on patient status based on best clinical judgment following the Stupp protocol. Patient can receive second treatment of HSV-tk after 6 months.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,313 Total Patients Enrolled

4 Trials studying Glioblastoma

86 Patients Enrolled for Glioblastoma

David S. Baskin, MDPrincipal InvestigatorHouston Methodist Neurological Institute

Media Library

ADV/HSV-tk (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03603405 — Phase 1 & 2

Glioblastoma Research Study Groups: Experimental: ADV/HSV-tk (gene therapy)

Glioblastoma Clinical Trial 2023: ADV/HSV-tk Highlights & Side Effects. Trial Name: NCT03603405 — Phase 1 & 2

ADV/HSV-tk (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03603405 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people fit the requirements for participation in this research project?

"That is accurate, the trial information on clinicaltrials.gov reveals that the study is looking for additional participants. The study was first posted on February 28th, 2018, with the most recent update being on September 3rd, 2020. The study is looking for 62 individuals at 1 location."

Answered by AI

Are there any current openings for new enrollees in this clinical trial?

"Yes, this trial is still recruiting patients. According to the information available on clinicaltrials.gov, the trial was first posted on February 28th, 2018 and was most recently updated on September 3rd, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

David Baskin MD 2018. "HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03603405.

All > Glioblastoma Houston > Anaplastic Astrocytoma