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Gene Therapy + Radiotherapy for Brain Tumor
Study Summary
This trial tests a therapy combo for recurrent brain tumors to find the best dose to use.
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 can care for myself but may need occasional help.My immune system is weak and I easily get serious viral infections.I am not on immunosuppressive therapy, except for corticosteroids.It has been over 4 weeks since my last non-nitrosourea chemotherapy.My recurrent tumor can be partially or completely surgically removed.It has been over 6 weeks since I finished chemotherapy that included nitrosourea.My brain tumor has shown signs of growing or returning on scans.I am not a candidate for surgery to remove my cancer.I do not have an immune disorder or take immunosuppressive drugs.I currently have an infection.My brain tumor is confirmed and suspected to have grown before surgery.It has been over 3 months since my last radiation treatment.I don't have any health or mental conditions that would stop me from safely participating in the trial.I have had liver disease, such as autoimmune or viral hepatitis.I have recovered from major side effects of my previous treatment.I will use barrier protection during and for 3 months after my virus treatment.I haven't had gene, virus, immunotherapy, or certain other treatments for my tumor.My organ functions are normal.I am considered a candidate for surgery to remove tumor regrowth, as agreed by a team of cancer specialists.I will use birth control during and for 3 months after my treatment.My brain surgery won’t open into the brain’s fluid spaces.My kidneys work well enough (creatinine clearance ≥ 50 mL/min).I am 18 or older, can give consent, and agree to follow the study rules.
- Group 1: Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm
- 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 extensive is the participant pool for this clinical research trial?
"Affirmative. Records on clinicaltrials.gov illustrate that this research is actively enrolling participants; the trial was initially published on November 29th 2022 and updated most recently on January 9th 2023. For now, 18 patients are needed at a single site."
Are there any opportunities for new enrollees to join this research endeavor?
"Affirmative. According to clinicaltrials.gov, this scientific research has begun recruiting and is open for new participants. The trial was posted on November 29th 2022 with the last update occurring on January 9th 2023. 18 patients are needed at one site for the experiment's completion."
Has the Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm been given official authorization by the FDA?
"Our team at Power has calculated that the safety of Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm is a 1 due to this being an early phase trial which does not have much evidence for efficacy or safety."
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