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Purpose

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Cohort-specific inclusion for male and female patients. a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following: - Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions. - Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years. - Non-breast cancer patients exposed to other anticancer therapies within the past 3 years. b. Cohort B (prior cranial radiation) - Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors. - Life expectancy > 6 months 2. Washout from investigational and conventional interventions is up to the discretion of the investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study. 3. ≥18 years of age 4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment. 5. Able to provide informed consent. 6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. 7. Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes. - Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

Exclusion Criteria

  1. Cohort-specific exclusion for male and female patients: 1. Cohort A (no prior cranial radiation) - History of or current presence of primary brain tumors or brain metastases. 2. Cohort B (prior cranial radiation) - Diagnosed with high grade glioma. 2. Unwilling to undergo neuropsychological assessments necessary for the study. 3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy. a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy. 4. History of suspected hypersensitivity to riluzole or to any of its excipients. 5. Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole. 6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN) 7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Riluzole 		Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks
  • Drug: Riluzole
    Given PO
    Other names:
    • RILUTEK
Placebo Comparator
Placebo 		Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks
  • Drug: Placebo
    Given PO

Recruiting Locations

Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California 92868
Contact:
Alexandre Chan, PharmD, MPH
877-827-8839
ucstudy@uci.edu

More Details

Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
1-877-827-8839
ucstudy@uci.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.