ADV/HSV-tk (gene therapy) for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma+2 More
ADV/HSV-tk (gene therapy) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 (AA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioblastoma

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 60 months measured in months

Month 60
Overall Survival in months up to 5 years from Study drug administration (Day 0)
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 Safety

Safety Progress

1 of 3

Other trials for Glioblastoma

Trial Design

1 Treatment Group

Experimental: ADV/HSV-tk (gene therapy)
1 of 1
Experimental Treatment

62 Total Participants · 1 Treatment Group

Primary Treatment: ADV/HSV-tk (gene therapy) · No Placebo Group · Phase 1 & 2

Experimental: ADV/HSV-tk (gene therapy)
Drug
Experimental Group · 1 Intervention: ADV/HSV-tk (gene therapy) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months measured in months

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
236 Previous Clinical Trials
35,390 Total Patients Enrolled
4 Trials studying Glioblastoma
86 Patients Enrolled for Glioblastoma
David S. Baskin, MDPrincipal InvestigatorHouston Methodist Neurological Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must practice an effective method of birth control.
You have a serum creatinine level of < 1.5 mg/dL.
You are willing to provide biopsies as required by the study.
You are not eligible for this study if you have a life expectancy of less than 12 weeks.
Patient can receive second treatment of HSV-tk after 6 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.