What side effects are associated with this type of intervention?

Common treatments for brain metastases, such as whole-brain radiation therapy (WBRT), often lead to side effects including fatigue, hair loss, nausea, and cognitive decline. Radioprotective agents like BMX-001, which aim to protect normal tissues and enhance tumor inhibition, may help mitigate some of these side effects. However, the specific side effects of BMX-001 are still under investigation. General side effects of radiation therapy can also include skin irritation, headaches, and potential long-term neurocognitive effects.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved treatments for brain metastases that offer radioprotection of normal tissues and augmentation of tumor growth inhibition similar to BMX-001. However, BMX-001 is currently being studied for its potential to protect normal tissues from radiation-induced injury while enhancing tumor growth inhibition in patients undergoing whole-brain radiation therapy.

What other types of research exist?

Promising alternatives to BMX-001 for brain metastases patients include SB415286, a GSK-3β inhibitor that protects against radiation-induced brain necrosis, and BIBW 2992, an EGFR/ErbB tyrosine kinase inhibitor that enhances the anti-proliferative effects of irradiation in tumor models.

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BMX-001 + Radiotherapy for Brain Metastases

Phase 1 & 2

Waitlist Available

Led By John Kirkpatrick, MD

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 a non-small cell lung cancer, breast cancer, melanoma or renal cell cancer primary

Plan to be treated with WBRT to a dose of 30 Gy in 10 fractions

Must not have

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Prior whole brain radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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 brain tissue from radiation damage and enhance the treatment's effectiveness against tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of BMX-001 aren't detailed here but may include typical reactions related to new pharmaceuticals such as allergic responses, issues from drug interactions, or complications from underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is either lung, breast, skin (melanoma), or kidney cancer.

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I am scheduled for whole brain radiation therapy with a specific dose.

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I am 18 years old or older.

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I am mostly able to care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and willing to use birth control during the study due to risks.

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I have had whole brain radiation therapy before.

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I need 3 or more medications to control my high blood pressure.

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I have fainted in the last 6 months.

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I have cancer that has spread to the lining of my brain and spinal cord.

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My heart's electrical cycle is longer than normal.

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I have not needed IV antibiotics for an infection in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess safety and tolerability of WBRT + BMX-001 through proportion of patients who experience grade 4 or 5 study drug related adverse events.

Compare neurocognition in WBRT + BMX-001 vs. WBRT alone using cumulative score of HVLT-R, TMT A&B and COWA over time.

Secondary study objectives

Compare distant brain failure rate in WBRT + BMX-001 vs WBRT alone

Compare local recurrence rate in WBRT + BMX-001 vs WBRT alone

Compare rate of neurologic death in WBRT + BMX-001 vs WBRT alone

+1 more

Other study objectives

Compare QoL in WBRT + BMX-001 vs WBRT alone

Compare rate of radionecrosis in WBRT + BMX-001 vs WBRT alone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: WBRT + BMX-001Active Control2 Interventions

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).

Group II: Whole Brain Radiation TherapyActive Control1 Intervention

Whole brain radiation therapy per standard of care.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain metastases include whole-brain radiotherapy (WBRT), stereotactic radiosurgery (SRS), and systemic therapies such as targeted agents and immunotherapy. WBRT and SRS work by delivering high doses of radiation to destroy cancer cells, but they can also damage normal brain tissue. BMX-001, a novel treatment under investigation, aims to protect normal tissues from radiation-induced injury while enhancing the inhibition of tumor growth. This dual mechanism is crucial for brain metastases patients as it potentially reduces the side effects of radiation therapy, preserving cognitive function and quality of life, while effectively targeting and controlling tumor progression.

The influence of the blood-brain barrier in the treatment of brain tumours.Treatment of brain metastases in the modern genomic era.Hypoxia in Gliomas: Opening Therapeutical Opportunities Using a Mathematical-Based Approach.