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Virus Therapy

Gene Therapy for Glioblastoma

Houston Methodist Neurological Institute, Houston, TX
Targeting 2 different conditionsADV/HSV-tk (gene therapy)Phase 1 & 2RecruitingLed by David S. Baskin, MDResearch Sponsored by The Methodist Hospital Research Institute

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.

Eligible Conditions
  • Glioblastoma
  • Anaplastic Astrocytoma

Eligibility Criteria

Inclusion Criteria

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


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
252 Previous Clinical Trials
76,247 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
~0 spots leftby Dec 2023