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MW151 for Cognitive Impairment Due to Brain Radiation Therapy (MW151-102 Trial)
Phase 1
Recruiting
Led By Vinai Gondi, MD
Research Sponsored by ImmunoChem Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MW151-102 Trial Summary
This trial will study if MW151 can help reduce cognitive dysfunction caused by brain radiation therapy.
Who is the study for?
This trial is for adults with brain metastases from solid tumors who can consent, speak English, and have had a recent confirmation of malignancy. They must not be pregnant or have severe health issues like heart failure, infections needing IV antibiotics, jaundice due to liver problems, frequent seizures despite medication, significant psychiatric disorders or substance abuse within the last 5 years.Check my eligibility
What is being tested?
The study tests if MW151 can prevent cognitive decline when given during whole-brain radiotherapy for patients with intracranial metastases. It's based on evidence that MW151 reduces brain inflammation and improves cognition in animal models.See study design
What are the potential side effects?
While specific side effects of MW151 are not listed here, potential risks may include allergic reactions to its components as noted in the exclusion criteria. Side effects related to brain inflammation reduction will be monitored.
MW151-102 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Anti-inflammatory effects
Exploratory objective: brain age analysis in patiens undergoing whole-brain radiotherapy plus MW151
Progression-free survival and overall survival
+1 moreMW151-102 Trial Design
1Treatment groups
Experimental Treatment
Group I: Safety and tolerability evaluationExperimental Treatment1 Intervention
Part A: Open Label sentinel cohort 10 subjects will receive MW151 in an open label safety evaluation.
Part B: Open Label 30 subjects will receive MW151.
Find a Location
Who is running the clinical trial?
Northwestern MedicineOTHER
10 Previous Clinical Trials
8,502 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,966 Total Patients Enrolled
ImmunoChem Therapeutics, LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer was confirmed by a lab test within the last 5 years.My brain scans show cancer has spread to my brain.I am willing and able to sign the consent form after understanding the study's risks and benefits.
Research Study Groups:
This trial has the following groups:- Group 1: Safety and tolerability evaluation
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.
Are we still looking for human participants for this experiment?
"The clinical trial is recruiting participants, as noted on clinicaltrials.gov. This information is up-to-date as of the most recent update on July 8th, 2022. The trial was originally posted on July 1st, 2020."
Answered by AI
What are the risks associated with treatment using MW151?
"Given that this is a phase 1 trial with limited safety and efficacy data, our team at Power has given MW151 a score of 1."
Answered by AI
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