RecruitingPhase 1Phase 2NCT01913106

HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer

Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease


Sponsor

The Methodist Hospital Research Institute

Enrollment

25 participants

Start Date

Jun 1, 2007

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a gene therapy (called HSV-tk, which makes tumor cells sensitive to a virus-killing drug called valacyclovir) to standard radiation seed treatment (brachytherapy) improves outcomes for people with a recurrent brain tumor called glioblastoma. **You may be eligible if...** - You have been diagnosed with glioblastoma (an aggressive brain tumor) that has come back after prior treatment - You are a candidate for brachytherapy (small radioactive seeds placed inside the tumor) - You are at least 18 years old and in reasonable overall health - Your tumor meets certain size and location requirements **You may NOT be eligible if...** - You cannot take the antiviral drug valacyclovir (for example, due to kidney problems or allergy) - You have had certain prior brain radiation treatments that would make this combination unsafe - You are pregnant or breastfeeding - You have serious infections or significantly reduced immune function - Your overall health is too poor to tolerate the procedure 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

DRUGHSV-tk +Valacyclovir in Combination with Brachytherapy

The investigators insert a gene from a herpes simplex virus (HSV), which is a small piece of the basic structure of the virus, into the prostate gland tumor cells. The gene is called the thymidine kinase (tk) gene, which the cell uses to make a protein that can change valacyclovir, The way the tk gene will be transported into the tumor cells is by using a vector or "vehicle" to carry the tk gene into the cells. In this case the vector is a virus - an adenovirus. Scientists at the Department of Cell and Gene Therapy at The Methodist Hospital removed a portion of the adenovirus' genetic material that allows it to replicate so that it cannot cause infections. In place of the removed genetic material the scientists inserted the tk gene. Now the vector can carry the tk gene into tumor cells. When the vector/gene combination gets into tumor cells, it inserts itself into the cells' command center (nucleus) and tells the tumor cells to begin making thymidine kinase protein.


Locations(1)

Houston Methodist

Houston, Texas, United States

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NCT01913106


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