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BMX-001 + Chemoradiation for Brain Cancer (BMX-HGG Trial)

Phase 2
Waitlist Available
Led By Katherine Peters, MD, PhD
Research Sponsored by BioMimetix JV, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have histologically confirmed diagnosis of World Health Organization (WHO) grade III or IV malignant glioma
Subjects must be planning to start standard of care radiation therapy and chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with a recent (within 12 weeks) surgical intervention for high-grade glioma, WHO grade III or IV. They must be ready to start standard radiation and chemotherapy, have good organ function and performance status, agree to use contraception if sexually active, and not have any severe infections or other health conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing BMX-001 in combination with standard radiation therapy and temozolomide in patients newly diagnosed with high-grade glioma. The goal is to see if BMX-001 improves survival rates and cognitive functions compared to the standard treatment alone. Patients are randomly assigned to either receive BMX-001 along with chemoradiation or just chemoradiation.See study design
What are the potential side effects?
Potential side effects of BMX-001 when used alongside radiation therapy and temozolomide may include reactions at the injection site, general discomfort, possible impact on blood counts leading to increased risk of infection or anemia, as well as potential interference with liver function.

BMX-HGG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a high-grade brain tumor.
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I am planning to start standard radiation and chemotherapy treatments.
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I had surgery for brain cancer less than 12 weeks ago.
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I had surgery to remove a tumor, and the remaining visible part is 3 cm or smaller.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.

BMX-HGG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 - Overall survival
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Progression-free survival
Protection of Bone Marrow against Chemotherapy-Induced Thrombocytopenia
+2 more

BMX-HGG Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation Therapy, TMZ and BMX-001Experimental Treatment3 Interventions
Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase.
Group II: Radiation Therapy and TMZActive Control2 Interventions
In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide [TMZ]). A total of 80 subjects will be in this study arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMX-001
2017
Completed Phase 2
~30
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

BioMimetix JV, LLCLead Sponsor
9 Previous Clinical Trials
544 Total Patients Enrolled
Duke Cancer InstituteOTHER
16 Previous Clinical Trials
2,907 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,507 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02655601 — Phase 2
Brain Tumor Research Study Groups: Radiation Therapy, TMZ and BMX-001, Radiation Therapy and TMZ
Brain Tumor Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT02655601 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02655601 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~24 spots leftby Apr 2025