RecruitingPhase 1Phase 2NCT03603405

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination With Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.


Sponsor

The Methodist Hospital Research Institute

Enrollment

62 participants

Start Date

Feb 28, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a gene therapy approach combined with standard radiation therapy and chemotherapy (temozolomide) for people who have just been diagnosed with a highly aggressive brain cancer called glioblastoma (GBM) or anaplastic astrocytoma. The gene therapy uses a virus to plant a cancer-killing gene directly into the tumor. **You may be eligible if...** - You have been newly diagnosed with glioblastoma or anaplastic astrocytoma, confirmed by surgical biopsy - Your tumor is in a single location (not spread to multiple areas) and does not involve the brainstem - You have had surgery for this tumor and need further treatment - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have cancer in multiple locations in the brain or in the brainstem - You are pregnant or unable to tolerate chemotherapy or radiation - You have had prior radiation to the brain - Your general health is very 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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NCT03603405


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