MW151 and HA-WBRT in Patients With Brain Metastases

• Status: Not yet recruiting
• Trial end date: 2024-08-14
• Target enrollment: 0
• Participant gender: All

Summary

HYPOTHESIS: MW151 intervention will attenuate radiation induced cognitive impairment caused by hippocampal-avoidant whole brain radiation therapy (HA-WBRT) for brain metastases.

RATIONALE: There is non-clinical evidence that MW151 reduces brain inflammation and improves neurocognitive outcomes in animal models of radiation therapy induced cognitive dysfunction, and in animal models of other CNS disorders.

PURPOSE: This feasibility trial will study MW151 as a mitigator of cognitive dysfunction caused by HA-WBRT in adult patients with brain metastases from solid tumors, as compared with a control group of patients receiving HA-WBRT and placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoChem Therapeutics, LLC
• Collaborators: National Cancer Institute (NCI); Northwestern Medicine

Criteria

IInclusion Criteria:

• A subject will be eligible for inclusion in the study only if all of the following criteria are met:

1. All patients must be willing to and have the capacity to give written informed consent and have signed and dated the informed consent form in accordance with ICH and GCP guidelines

2. All patients must be able to speak and understand English proficiently

3. Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years

a. If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)

4. Brain metastases must be visible on contrast-enhanced MRI

a. Patients who had undergone radiosurgery or surgical resection and are planning adjuvant HA-WBRT do not have to have visible disease but do need a baseline MRI

5. Karnofsky performance status 70-100%

6. Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min as determined by Cockcroft-Gault

7. Negative urine pregnancy test within 14 days of Day 1 for Women of Childbearing Potential

8. Women of childbearing potential and men with female partners of childbearing potential must have no plans for further conception and must practice adequate contraception

Exclusion Criteria:

• A subject will not be eligible for inclusion in the study if any of the following criteria are met:

1. Subject is lactating or is pregnant

2. Severe, active co-morbidity, defined as follows:

1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

2. Transmural myocardial infarction within the last 6 months

3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

3. Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)

4. Clinically significant abnormalities in screening laboratory tests that would affect patient safety as determined by the principal investigator

5. History of psychiatric disorder requiring ongoing medical management

6. History of substance abuse including alcohol within past 5 years. Appropriately prescribed medication for the treatment of pain or other symptoms related to the underlying malignancy is acceptable

7. Chronic kidney disease defined as the presence of significant proteinuria on urinalysis and/or eGFR of <60mL/min, as calculated by the clinical site laboratory

8. Inability to follow the instructions or an unwillingness to cooperate with study procedures

9. Known allergy to any component of MW151 or placebo as described in investigator's brochure

10. Received treatment with and/or planned treatment with systemic chemotherapy within 3 days prior, during, or for at least 3 days after completion of HA-WBRT.

Concurrent immunotherapy is permitted

11. Prior whole-brain radiotherapy

12. Use of chronic short-acting benzodiazepine

13. Use of NSAIDS or steroids within 3 days prior to dosing

14. Any reason or opinion of the investigator that would prevent the subject from participation in the study