BMX-001 + Radiotherapy for Brain Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BMX-001, used alongside standard whole brain radiation therapy for individuals with multiple brain metastases—cancerous growths that have spread to the brain. The researchers aim to determine if BMX-001 can protect healthy brain tissue from radiation and inhibit tumor growth. Suitable candidates have specific cancer types, such as lung, breast, melanoma, or kidney, and more than five brain tumors not previously treated with surgery or certain focused radiation. As a Phase 1 trial, this research seeks to understand how BMX-001 works in people, offering participants the chance to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial protocol mentions that if you are taking any prohibited medications, you may need to stop them at least 7 days before the first dose of BMX-001, but this is at the discretion of the treating physician. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMX-001 might be safe for humans. Studies have found that BMX-001, when used with radiation therapy, is generally well-tolerated. For instance, in patients with high-grade glioma, BMX-001 was safe when combined with radiation and a common chemotherapy drug. Another study found that BMX-001 did not cause major side effects and helped protect healthy tissues from radiation damage. This suggests that BMX-001 might also be safe for people with multiple brain tumors receiving whole brain radiation therapy. However, this treatment is still under investigation, and more research is needed to fully understand its safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about BMX-001 for brain metastases because it offers a novel approach by combining an antioxidant with whole brain radiation therapy (WBRT). Unlike standard treatments like WBRT alone, which primarily target cancer cells with radiation, BMX-001 works by reducing oxidative stress and protecting healthy brain tissue during radiation. This unique mechanism of action has the potential to enhance the effectiveness of radiation therapy while minimizing damage to normal brain cells, which could lead to better outcomes and fewer side effects for patients.
What evidence suggests that BMX-001 might be an effective treatment for brain metastases?
In this trial, participants will receive either whole brain radiation therapy (WBRT) alone or WBRT combined with BMX-001. Research has shown that BMX-001, when used with WBRT, may protect healthy tissues from radiation damage and slow tumor growth. Early studies suggest that this medication can enhance the effectiveness of radiation therapy in treating cancer that has spread to the brain. Specifically, BMX-001 has been reported to improve survival rates and reduce memory and thinking problems in patients with advanced brain cancer. These promising results indicate that BMX-001 could make radiation therapy more effective and less harmful to healthy brain tissue when treating multiple brain tumors. Overall, the early evidence supports its potential benefits in this context.14678
Who Is on the Research Team?
John Kirkpatrick, MD
Principal Investigator
Duke Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with certain cancers (non-small cell lung, breast, melanoma, or renal cell) that have spread to the brain. They must be fit enough for radiotherapy and not previously treated with specific surgeries or radiosurgery. Pregnant women and those unable to use contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-In
Initial safety lead-in phase with 5 patients to assess safety of BMX-001 in combination with WBRT
Randomized Treatment
Randomized Phase 2 trial where half of the 64 patients receive BMX-001 with WBRT and half receive WBRT alone
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neurocognition and survival assessments
What Are the Treatments Tested in This Trial?
Interventions
- BMX-001
Trial Overview
The study tests BMX-001 in patients undergoing whole-brain radiation therapy for multiple brain metastases. It starts with a safety phase for 5 patients followed by a randomized test on 64 more to see if BMX-001 protects healthy tissue and helps control tumor growth.
How Is the Trial Designed?
2
Treatment groups
Active Control
Whole brain radiation therapy in combination with BMX-001 (subcutaneous injection of 28 mg loading dose, followed by subsequent 14 mg twice per week for 2 weeks).
Whole brain radiation therapy per standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioMimetix JV, LLC
Lead Sponsor
Duke Cancer Institute
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
A Trial for Treatment of Cancer Patients With Multiple Brain ...
Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.
Trial of Newly Diagnosed High Grade Glioma Treated With ...
BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against ...
BMX-001 + Radiotherapy for Brain Metastases
This trial tests BMX-001, a new medicine, in patients with multiple brain metastases receiving whole brain radiation therapy. BMX-001 aims to protect healthy ...
BMX-001 as a Therapeutic Agent for Treatment of Multiple ...
Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition. ...
5.
neurosurgery.duke.edu
neurosurgery.duke.edu/news/drug-born-duke-improves-survival-people-advanced-brain-cancerDrug born at Duke improves survival in people with ...
BMX-001 has been shown to improve survey and lessen cognitive decline in people with advanced brain cancer.
ACTR-28. PHASE 1 DOSE ESCALATION TRIAL OF THE ...
BMX-001 with RT plus TMZ and post-RT TMZ for patients with newly diagnosed HGG was safe and well-tolerated. Phase II study with BMX-001 in combination with ...
LTBK-09. RESULTS OF BMX-HGG STUDY: A MULTI ...
BMX-001 is a novel metalloporphyrin that radiosensitizes cancer ... BMX-001 is safe, and there is improved OS in HGG patients receiving BMX-001.
Therapeutic Potential of BMX-001 for Preventing ...
This differential regulation of inflammation and antioxidant activity aligned with data showing that BMX-001 enhanced tumor cytotoxicity in ...
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