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BMX-001 + Chemoradiation for Brain Cancer (BMX-HGG Trial)
BMX-HGG Trial Summary
This trial is testing a new drug, BMX-001, to see if it can help people with high grade glioma (HGG) live longer and improve their cognition and quality of life. BMX-001 will be given in addition to standard radiation therapy and temozolomide (chemoradiation).80 patients will be given BMX-001 and 80 will just receive chemoradiation to compare the two groups.
BMX-HGG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBMX-HGG Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BMX-HGG Trial Design
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Who is running the clinical trial?
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- I have not needed IV antibiotics for an infection in the last 7 days.I have signs of infection or healing issues where my brain surgery was done.I am not currently being treated for cancer, except for early-stage cervical, basal cell, or squamous cell skin cancer.My brain scan shows bleeding more severe than grade 1.I haven't taken drugs that strongly affect liver enzymes recently.My high blood pressure is not well-controlled.I have had issues with sudden drops in blood pressure when standing.I am planning to start standard radiation and chemotherapy treatments.I had surgery for brain cancer less than 12 weeks ago.I had surgery to remove a tumor, and the remaining visible part is 3 cm or smaller.I am able to care for myself but may not be able to do active work.My steroid dose has been stable or decreasing for over a week.I have a brain condition like seizures, but it's under control with medication.My heart's electrical cycle is longer than normal.I haven't had major blood vessel problems or surgery for them in the last 6 months.I haven't had a serious heart or stroke issue in the last 6 months.I have risk factors for a specific heart rhythm problem (like heart failure or low potassium).I have been diagnosed with a high-grade brain tumor.I am 18 years old or older.I have had chemotherapy or radiotherapy for a brain tumor before.I am not taking any medication that could affect the study, except for corticosteroids.
- Group 1: Radiation Therapy, TMZ and BMX-001
- Group 2: Radiation Therapy and TMZ
- 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
Has research of this type been conducted before?
"Currently, 209 studies of Radiation Therapy are active in 935 cities and 36 nations. The inaugural study was conducted by Schering-Plough back in 2002 with 60 participants, eventually entering Phase 2 drug approval. Subsequently, 398 trials have been concluded since then."
Can you provide me with a summary of prior experiments employing Radiation Therapy?
"In 2002, Memorial Sloan Kettering Cancer Center conducted the first radiation therapy research. To date, 398 trials have been completed with 209 actively recruiting at various sites, particularly in Birmingham Alabama."
What malignancies can be ameliorated through Radiation Therapy?
"Nitrosourea treatment is frequently administered via Radiation Therapy, however this technique can also be utilized to address mineral supplementation, directives for end-of-life care, and refractory cases of mycosis fungoides."
In what areas is this clinical experiment currently conducted?
"At present, there are 9 clinical sites that are enrolling participants. These locations include Birmingham and Durham in addition to San Francisco plus six other hubs. To minimise travelling demands, it is important for those interested to opt for the nearest site possible."
How many participants is this research endeavor recruiting?
"Unfortunately, this clinical investigation is no longer recruiting new participants. It was first published on September 25th 2018 and last edited nearly four years later on the 26th of September 2022. For those searching for other studies involving glioblastoma there are currently 714 trials open to enrollment, with an additional 209 Radiation Therapy trials in need of patients."
Has Radiation Therapy been granted authorization from the FDA?
"Our team at Power classified radiation therapy as a level 2 on the safety scale, since there are clinical data that confirms its security but no efficacy studies."
Is recruitment still ongoing for this experiment?
"The research project posted on clinicaltrials.gov is not seeking participants at this juncture, as it has last been updated in September of 2022. However, there are 923 other studies which remain actively recruiting prospective volunteers."
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