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ITI-1001 for Glioblastoma
Study Summary
This trial will test a new drug to treat people with glioblastoma, a brain tumor. It'll check how safe & effective the drug is.
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 do not have severe symptoms like intense headaches, vomiting, or changes in consciousness due to high brain pressure.My cancer is mainly in my spinal cord, brain stem, has spread widely, or is significantly affecting the lining of my brain.I have had heart rhythm problems before joining the study.I have a known history of AIDS or HIV.I don't have metal implants where the treatment will be given.I am able to care for myself but may not be able to do active work.I have been newly diagnosed with a high-grade brain tumor.My kidney function is within the normal range.I had cancer treated to cure over 3 years ago with no current signs of it returning.I don't have any chronic or active neurological disorders that would affect my participation in the study, except for seizures due to GBM which are under control.I need to take dexamethasone within a week before my first ITI-1001 vaccine dose.I am scheduled for standard chemotherapy and radiation treatment.I am 18 years old or older.I have at least 2 good spots for injections that are free of tattoos, thick skin, or keloids.My blood tests show I have enough red cells, platelets, and white cells.My liver is functioning well, with normal bilirubin and enzyme levels.I had surgery to remove most of my tumor, and the MRI shows a very small amount left.
- 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 secure is the prognosis for individuals diagnosed with Glioblastoma (GBM)?
"Our team at Power has assessed the safety of Participants with Newly Diagnosed Glioblastoma (GBM) to be a 1, as this is only Phase 1 and there remains limited evidence in regards to its efficacy and security."
Has recruitment for this experiment commenced yet?
"Unfortunately, based on the information available through clinicaltrials.gov this trial is not currently enrolling new patients; although it was first posted in January 1st 2023 and last updated a little over two weeks later. At present, there are an abundance of other studies that may be actively seeking participants - 439 to be exact."
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