What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as radiation therapy and temozolomide, are associated with several side effects. Radiation therapy can lead to neurocognitive impairment, fatigue, hair loss, and skin reactions. Temozolomide, a chemotherapy agent, often causes nausea, vomiting, fatigue, and myelosuppression (decreased blood cell production). Long-term complications of these treatments may include neurocognitive decline, endocrine abnormalities, and an increased risk of secondary cancers. The addition of radioprotective agents like BMX-001 aims to mitigate some of these adverse effects, particularly cognitive deterioration and overall quality of life impairment.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, particularly high-grade gliomas. Temozolomide, an oral chemotherapy drug, is commonly used in combination with radiation therapy and has been a standard treatment for glioblastoma since its approval. Bevacizumab, an anti-angiogenic drug, has also been approved for recurrent glioblastoma. While specific radioprotective agents like BMX-001 are still under investigation, the combination of radiation therapy and temozolomide remains a cornerstone of brain tumor treatment.

What other types of research exist?

Promising novel alternatives to BMX-001 for brain tumor patients include: 1) Temozolomide, which has shown high efficacy against brain tumor xenografts and can be used in combination with other treatments. 2) TNP-470 combined with BCNU, which significantly inhibits tumor growth in glioblastoma xenografts without evident side effects. 3) Novel dimethylpyridazine derivatives, which have shown encouraging results in preclinical models of medulloblastoma. These alternatives may offer new avenues for enhancing treatment efficacy and patient outcomes in 2024.

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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

Must not have

A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1)

Active infection requiring IV antibiotics 7 days before enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests BMX-001, an injectable drug, added to standard radiation and chemotherapy for newly diagnosed aggressive brain cancer patients. The goal is to see if BMX-001 can improve survival and protect brain function.

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.

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.

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.

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.

Exclusion Criteria

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

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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.

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I have signs of infection or healing issues where my brain surgery was done.

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My brain scan shows bleeding more severe than grade 1.

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My high blood pressure is not well-controlled.

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I have had issues with sudden drops in blood pressure when standing.

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I haven't had a serious heart or stroke issue in the last 6 months.

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I have had chemotherapy or radiotherapy for a brain tumor before.

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I am not taking any medication that could affect the study, except for corticosteroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary study objectives

Phase 2 - Overall survival

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Progression-free survival

Protection of Bone Marrow against Chemotherapy-Induced Thrombocytopenia

+2 more

Awards & Highlights

No Placebo-Only Group

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

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

Radiation Therapy

2017

Completed Phase 3

~7250

Temozolomide

2010

Completed Phase 3

~1880

BMX-001

2017

Completed Phase 2

~30

0 / 15Eligibility 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 tumors include radiation therapy, temozolomide, and radioprotective agents like BMX-001. Radiation therapy damages the DNA of cancer cells, leading to their death. Temozolomide, an oral chemotherapy drug, adds methyl groups to DNA, preventing cancer cells from replicating. BMX-001 aims to protect normal brain cells from radiation damage while allowing radiation to target cancer cells. These mechanisms are important for brain tumor patients as they help maximize tumor control and minimize damage to healthy brain tissue, improving survival rates and quality of life.