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MW151 and HA-WBRT in Patients With Brain Metastases (MW151-102)

Primary Purpose

Cognitive Dysfunction, Cognitive Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MW151
Sponsored by
ImmunoChem Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction, Cognitive Disorder focused on measuring MW151, MW01-2-151SRM, whole brain radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Open Label

Part B: Randomized, placebo-controlled

Arm Description

10 subjects will receive MW151 in an open label evaluation.

30 subjects will be randomly assigned to MW151 or placebo in a 1:1 ratio.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.

Secondary Outcome Measures

Reduction in cognitive deterioration
To determine if the addition of MW151 to HA-WBRT standard of care treatment will show a trend towards reduction in cognitive deterioration in patients with brain metastases from solid tumors, as measured by standardized NCF tests.
Anti-inflammatory effects
To determine if the addition of MW151 to HA-WBRT will have an impact on plasma levels of proinflammatory cytokines (PIC).
Progression-free survival and overall survival
To evaluate intracranial progression-free survival and overall survival following the addition of MW151 to HA-WBRT standard of care treatment for patients with brain metastases.

Full Information

First Posted
June 6, 2022
Last Updated
July 8, 2022
Sponsor
ImmunoChem Therapeutics, LLC
Collaborators
National Cancer Institute (NCI), Northwestern Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05417282
Brief Title
MW151 and HA-WBRT in Patients With Brain Metastases
Acronym
MW151-102
Official Title
Safety and Tolerability of MW151 Administered With Hippocampal Avoidant Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 14, 2023 (Anticipated)
Study Completion Date
August 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoChem Therapeutics, LLC
Collaborators
National Cancer Institute (NCI), Northwestern Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
In Part A, 10 subjects will receive MW151 in an open label evaluation. At least 5 of these subjects will be male. For each subject, safety and tolerability data for the first 24 hours will be reviewed prior to the continuation of dosing. Subjects will also be evaluated for safety during week 1, during week 2, and at week 4. Once the data from Part A have been reviewed by the Safety Monitoring Committee (SMC), an additional 30 subjects will be recruited to Part B. These subjects will be randomly assigned to MW151 or placebo in a 1:1 ratio. In both parts A and B subjects will take study drug (males), or the first daily dose of study drug (females) before HA-WBRT which will be administered once a day (3Gy), five days a week (Monday to Friday) for two weeks, for total of ten treatments and 30 Gy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Cognitive Disorder
Keywords
MW151, MW01-2-151SRM, whole brain radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Open Label
Arm Type
Experimental
Arm Description
10 subjects will receive MW151 in an open label evaluation.
Arm Title
Part B: Randomized, placebo-controlled
Arm Type
Experimental
Arm Description
30 subjects will be randomly assigned to MW151 or placebo in a 1:1 ratio.
Intervention Type
Drug
Intervention Name(s)
MW151
Intervention Description
Females: 20 mg MW151 daily (10 mg capsule BID), for 28 days; Males: 10 mg MW151 daily (10 mg capsule QD), for 28 days.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Reduction in cognitive deterioration
Description
To determine if the addition of MW151 to HA-WBRT standard of care treatment will show a trend towards reduction in cognitive deterioration in patients with brain metastases from solid tumors, as measured by standardized NCF tests.
Time Frame
6 months
Title
Anti-inflammatory effects
Description
To determine if the addition of MW151 to HA-WBRT will have an impact on plasma levels of proinflammatory cytokines (PIC).
Time Frame
6 months
Title
Progression-free survival and overall survival
Description
To evaluate intracranial progression-free survival and overall survival following the addition of MW151 to HA-WBRT standard of care treatment for patients with brain metastases.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
IInclusion Criteria: A subject will be eligible for inclusion in the study only if all of the following criteria are met: 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 All patients must be able to speak and understand English proficiently 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) 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 Karnofsky performance status 70-100% Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min as determined by Cockcroft-Gault Negative urine pregnancy test within 14 days of Day 1 for Women of Childbearing Potential 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: Subject is lactating or is pregnant Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months) Clinically significant abnormalities in screening laboratory tests that would affect patient safety as determined by the principal investigator History of psychiatric disorder requiring ongoing medical management 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 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 Inability to follow the instructions or an unwillingness to cooperate with study procedures Known allergy to any component of MW151 or placebo as described in investigator's brochure 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 Prior whole-brain radiotherapy Use of chronic short-acting benzodiazepine Use of NSAIDS or steroids within 3 days prior to dosing Any reason or opinion of the investigator that would prevent the subject from participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Shifrin, PhD
Phone
(617) 872-0639
Email
vshifrin@ic-rx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Bowen, RN
Phone
(859) 396-4655
Email
bowen73@windstream.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinai Gondi, MD
Organizational Affiliation
Northwestern Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer Center
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MW151 and HA-WBRT in Patients With Brain Metastases

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