ADV/HSV-tk (gene therapy) for Glioblastoma
Phase-Based Progress Estimates
Effectiveness
Safety
Glioblastoma+2 More
ADV/HSV-tk (gene therapy) - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
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: DrugTrial 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 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.
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