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This trial is studying a combination of two immunotherapy drugs and stereotactic radiosurgery to see if it is safe and effective in treating patients with recurrent glioblastoma.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You stopped taking chemotherapy treatment that is not nitrosourea at least 3 weeks ago.You are expected to live for at least 3 more months.You have a significant brain swelling that could cause pressure in the middle of your brain.You have had a previous bone marrow or organ transplant.You have a heart condition that is not well-managed or is severe.You received a live vaccine within a month before taking the study drug.You can have received treatment for cancer before, but you can't have received a specific type of medication called bevacizumab or other vascular endothelial growth factor inhibitors unless it was given to treat radiation necrosis and stopped at least 4 weeks before a MRI scan showed your tumor was growing. If you received gliadel wafers, they can only have been given during your first surgery for GBM at the time of initial diagnosis.You have finished radiation therapy at least 12 weeks ago.You have received nitrosourea chemotherapy within the last 6 weeks.You have shown an allergic reaction to another type of antibody.You have had or currently have another type of cancer that may affect your safety or the evaluation of the study's effectiveness.You are currently pregnant.You can swallow pills or tablets.You have a type of brain tumor called glial tumor that has come back after previous treatment with radiation therapy. Your MRI scan shows clear signs of the tumor getting worse. The previous radiation dose you received was between 40-75 Gy with either photon or proton radiation.You cannot participate if you are already enrolled in another clinical trial that involves treatment.You have a history of lung inflammation that required treatment with steroids.You have a severe medical condition, ongoing infection, or serious illness that is not under control.You have been previously diagnosed with a weakened immune system.You have received medication for autoimmune or connective tissue disease recently or still undergoing treatment.You have a tumor that can be treated with stereotactic radiosurgery (SRS) and it needs to be at least 1cm x 1cm in size but no larger than 4cm in diameter. Your doctor will decide if you are a candidate for SRS and make sure the treatment won't cause harm. You can have more than one tumor as long as they meet these requirements.Only patients who need surgery as determined by their healthcare provider are eligible for Cohort B.You have been diagnosed with a specific type of brain cancer called glioblastoma or gliosarcoma. You may also be eligible if you were previously diagnosed with low-grade glioma and now have a diagnosis of glioblastoma.If you have had a brain tumor before, we need to know if your tumor has specific changes in a gene called MGMT. We will use standard tests to determine this.For Sub-Arms 2 of Cohort B, the size of your tumor does not matter, and it does not need to be treatable with SRS.If you are part of Sub-Arms 2 in Cohort B, the size of your tumor does not matter and it does not need to be treatable with SRS (Stereotactic Radiosurgery).
- Group 1: Cohort A
- Group 2: Cohort B sub-arm #1
- Group 3: Cohort B sub-arm #2
- 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
Is this a never-before-attempted clinical trial?
"Since 2016, there has been a steady progression of research surrounding Brain surgery. Incyte Corporation first sponsored the clinical trial in which 325 patients took part; and following its successful completion, Phase 1 drug approval was granted. Currently 26 trials are ongoing across 117 cities and 43 nations."
Are there any regulatory approvals for neurosurgical procedures?
"A score of 2 was assigned to brain surgery given that there is preliminary evidence for safety, but insufficient data on efficacy."
How many individuals have signed up to take part in the experiment?
"At the present time, this study is not accepting participants. The trial was posted on June 23rd 2020 and last updated on April 11th 2022. Other clinical trials that are currently in need of patients with glioblastoma include 441 different studies while 26 research sites require people undergoing brain surgery to join their respective projects."
Are there any notable investigations into the efficacy of Brain surgery?
"Currently, 26 studies researching Brain surgery are active with 3 trials in the final Phase. While most of these clinical investigations take place in A CORUï¿½A and Virginia, 810 medical centres worldwide are conducting them."
Does this experiment have any additional slots for people to participate?
"At present, this research project is no longer accepting new participants. Initially posted on June 23rd 2020 and last edited April 11th 2022, there are currently 441 ongoing studies recruiting patients with glioblastoma and 26 trials searching for volunteers to undergo brain surgery."
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