HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT03603405
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADV/HSV-tk (gene therapy) — DRUG
    The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy

Study Details

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).

Key Dates

Start date
Feb 28, 2018
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: ADV/HSV-tk (gene therapy)
    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.

Primary Outcome Measure

Overall Survival in months up to 5 years from Study drug administration (Day 0) [ Time Frame: Up to 60 months measured in months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Neurological InstituteHoustonTexas77030
David S. Baskin, MD
[email protected]
713-441-3800
Helga M. Jones
[email protected]
713-363-9388

Find similar trials in Houston, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Houston Methodist Neurological Institute· Houston, TX

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