RecruitingPhase 1Phase 2NCT03596086

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

Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme


Sponsor

David Baskin MD

Enrollment

62 participants

Start Date

Dec 11, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a gene therapy approach combined with radiation and chemotherapy for people whose brain tumor (glioblastoma or a related aggressive brain cancer) has come back after previous treatment. The gene therapy involves injecting a viral gene into the tumor, then giving an antiviral drug that turns the gene into a cancer-killing agent. **You may be eligible if...** - You have been diagnosed with recurring glioblastoma (GBM) or anaplastic astrocytoma, confirmed by biopsy or imaging - Your cancer has returned and shows up on scans as a single, localized area (not in multiple spots) - You are in good general health (ECOG 0-1) - It has been at least 3 weeks since your last surgery, radiation, or systemic treatment - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your tumor has spread to multiple areas or involves the brainstem - You are pregnant - You have had recent major surgery within the last 3 weeks - Your general health is poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADV/HSV-tk (gene therapy)

The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy


Locations(1)

Houston Methodist Neurological Institute

Houston, Texas, United States

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NCT03596086


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