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Gene Therapy + Chemoradiotherapy for Glioblastoma
Study Summary
This trial is studying how well HSV-tk (gene therapy), valacyclovir, radiotherapy, and chemotherapy work in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am using effective birth control methods.I am under 18 years old.I can have a second HSV-tk treatment after 6 months.I have not recently had chemotherapy, radiation, immunotherapy, or experimental drugs.My biopsy shows I have a specific brain tumor without it spreading in my brain.I have no active cancer except possibly skin cancer.I am willing to undergo biopsy procedures as needed.I haven't had immunotherapy or gene therapy in the last 3 months.My cancer has spread to multiple areas or the brainstem.I cannot swallow pills due to a condition in my upper digestive tract.My cancer has spread to my brainstem or is widely affecting the lining of my brain and spinal cord.I have an active skin infection or wound that hasn't been treated.I do not have an ongoing infection or a weakened immune system.I have been newly diagnosed with a high-grade brain tumor.I had surgery for a brain tumor and need another one for remaining cancer.I am fully active or can carry out light work.I may have cancer cells in the fluid around my brain and spinal cord.My organ functions are within normal ranges according to recent tests.I do not have an active brain infection.I have liver disease, like cirrhosis or hepatitis B/C.I have no active cancer except for certain allowed types.I am currently taking drugs that suppress my immune system.
- Group 1: Experimental: ADV/HSV-tk (gene therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people fit the requirements for participation in this research project?
"That is accurate, the trial information on clinicaltrials.gov reveals that the study is looking for additional participants. The study was first posted on February 28th, 2018, with the most recent update being on September 3rd, 2020. The study is looking for 62 individuals at 1 location."
Are there any current openings for new enrollees in this clinical trial?
"Yes, this trial is still recruiting patients. According to the information available on clinicaltrials.gov, the trial was first posted on February 28th, 2018 and was most recently updated on September 3rd, 2020."
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