HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Part of paid clinical trials in Houston, Texas.

Sponsor
David Baskin MD
Study ID
NCT03596086
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Astrocytoma, Grade III
  • Glioblastoma Multiforme

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 recurrent glioblastoma multiforme.

Key Dates

First listed
Jul 23, 2018
Start date
Dec 11, 2017
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • 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 10 sessions (over 2 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent or after completion of the radiotherapy dependent on patient status based on best clinical judgment. Patient can receive second treatment of HSV-tk after 6 months

Primary Outcome Measure

Survival in months from Study drug administration (Day 0) [ Time Frame: Up to 60 months as 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 research site
Houston Methodist Neurological Institute· Houston, TX

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