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BMX-001 + Radiotherapy for Brain Metastases
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, BMX-001, to see if it is safe and effective in treating brain cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
Compare QoL in WBRT + BMX-001 vs WBRT alone
Compare rate of radionecrosis in WBRT + BMX-001 vs WBRT alone
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.
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Who is running the clinical trial?
BioMimetix JV, LLCLead Sponsor
9 Previous Clinical Trials
635 Total Patients Enrolled
Duke Cancer InstituteOTHER
16 Previous Clinical Trials
2,998 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to substances that are similar to BMX-001.My cancer is either lung, breast, skin (melanoma), or kidney cancer.I can stop taking certain medications 7 days before starting the trial, if my doctor agrees.I am not pregnant and willing to use birth control during the study due to risks.I have had whole brain radiation therapy before.Your hemoglobin level is at least 9.0 g/dl, your ANC (a type of white blood cell) count is at least 1,500 cells/µl, and your platelet count is at least 125,000 cells/µl.Your blood tests show that your creatinine, SGOT, and bilirubin levels are within a certain range.I need 3 or more medications to control my high blood pressure.I am not on medication that could dangerously lower my blood pressure.I have fainted in the last 6 months.I have cancer that has spread to the lining of my brain and spinal cord.My heart's electrical cycle is longer than normal.I am 18 years old or older.I have more than 5 untreated brain lesions, with at least one larger than 0.5cm.I have been examined by a cancer specialist within the last 2 weeks.I am scheduled for whole brain radiation therapy with a specific dose.I am mostly able to care for myself.Women who could become pregnant need to have a negative pregnancy test within 48 hours before starting the study medication.I have not needed IV antibiotics for an infection in the last 7 days.I am willing to follow the study's procedures and complete all required tests and questionnaires.I had surgery or targeted radiation for brain metastases over a month ago.I have risk factors for a rare heart rhythm condition (like heart failure or low potassium).
Research Study Groups:
This trial has the following groups:- Group 1: WBRT + BMX-001
- Group 2: Whole Brain Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period of this investigation still ongoing?
"The information posted on clinicaltrials.gov specifies that this experiment is currently recruiting patients. It was initially published on October 4th 2018, and the most recent edit occurred on September 26th 2022."
Answered by AI
How many individuals are taking part in this research endeavor?
"In order to initiate this study, 69 individuals that meet the requirements must be identified. Recruitment is taking place at various locations such as Henry Ford Hospital in Detroit and University of Kentucky in Lexington."
Answered by AI
What aims is this research attempting to achieve?
"This research aims to assess neurocognition in patients who receive WBRT + BMX-001 compared those receiving just WBRT, by measuring the cumulative score of HVLT-R, TMT A&B and COWA over a one year period. Secondary objectives involve establishing ratios for neurologic death caused by leptomeningeal carcinomatosis within 1 year of initiation of WBRT; calculating median time to local brain failure or progression; as well as survival rates between both groups."
Answered by AI
Are there multiple locations in the state administering this clinical research?
"This medical experiment is being performed at 4 distinct sites, located in Detroit, Lexington and Durham among other cities. To reduce transportation needs associated with the trial, it's recommended to choose a clinic close to you if you decide to join."
Answered by AI
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