Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (JAZZ)

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    36
  • sponsor
    Wake Forest University Health Sciences
Updated on 21 March 2022
cancer
karnofsky performance status
chemoradiotherapy
neutrophil count
malignant glioma
brain tumor
oligodendroglioma
tumor progression
mgmt gene

Summary

This phase II trial studies the side effects of solriamfetol in improving sleep in patients with grade II-IV glioma. Solriamfetol is a wakefulness-promoting drug. Giving solriamfetol may improve sleep, memory, fatigue, mood, or quality of life in patients with brain tumors (gliomas).

Description

Primary Objective:

I. To estimate the safety of solriamfetol at 75 mg daily, 150 mg daily, 300 mg daily as assessed by NCI CTC Adverse Events (v5.0) in patients with primary gliomas compared to prior studies.

Secondary Objective(s):

I. To estimate the effect of solriamfetol on sleep by Epworth Sleepiness Scores (ESS) scores in patients with primary gliomas and compare the effect to previously published scores in patients with OSA

II. To estimate the effect of solriamfetol on sleep quality by Pittsburgh Sleep Quality Index scores

III. To estimate the effect of solriamfetol on neurocognitive function based on a disease-specific neurocognitive battery (see neurocognitive battery below)

IV. To estimate the effect of solriamfetol on patient-reported fatigue (Brief Fatigue Inventory, Cancer Fatigue Scale) & mood (Beck's Depression Inventory)

V. To estimate the effect of solriamfetol on patient-reported QOL (FACT-Br)

VI. To estimate the effect of solriamfetol on objective sleep-wake times by actigraphy and sleep diary (pre- vs post-treatment)

Exploratory Objective(s)

I. To explore a biologic gradient effect of increasing doses of solriamfetol on actigraphy

II. To explore differences in clinical activity of solriamfetol by corticosteroid use, antiepileptic use, and tumor grade.

OUTLINE: This is a dose-escalation study.

Patients receive solriamfetol orally (PO) once daily (QD) for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Details
Condition Glioma, Glioblastoma
Treatment Soliramfetol
Clinical Study IdentifierNCT03868943
SponsorWake Forest University Health Sciences
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

WHO Grade 2-4 infiltrating glioma by histologic confirmation
Where appropriate results from clinically available testing of isocitrate dehydrogenase (IDH) gene mutation status (for all gliomas), chromosome 1p and 19q deletion status (for suspected oligodendrogliomas), and MGMT gene promoter methylation status (for malignant gliomas) must be available in the patient's chart
These studies are standard of care molecular studies that are performed as a part of routine clinical practice and allow for integrated molecular subtyping of primary glial tumors
Epworth Sleepiness Scale (ESS) score >10 within 21 days of enrollment
Clinical and/or radiographic evidence of stable disease within 21 days of
enrollment
Patients must have completed concurrent chemoradiation with recovery of all pre-existing toxicity to CTCAE Grade >1
Patient who are anticipated to undergo surgery and/or radiation therapy for management of their tumor during the duration of study treatment are NOT eligible
Patients who are anticipated to undergo adjuvant chemotherapy are eligible as long as there is no evidence of tumor progression by clinical exam and/or imaging within 21 days of enrollment (see 4.1.2). This determination should be made by clinical documentation and if there is question discussed with the Study Chair. Adjuvant chemotherapy is not an exclusion
Patients who are currently undergoing chemotherapy, targeted therapy, immunotherapy, or salvage treatment and have stable disease by imaging are eligible and can continue the current anti-cancer therapy. Patients who will require a new anti-cancer treatment or are anticipated to change anti-cancer treatments are not eligible
Age > 18 years
Karnofsky performance status ≥ 60%
Life expectancy of greater than 4 months
Patients must have normal organ and marrow function as defined below
leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total
bilirubin 1.5 X institutional upper limits of normal AST(SGOT)/ALT(SGPT) <2.5 X
institutional upper limit of normal creatinine within normal institutional limits OR
creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal
The effects of solriamfetol on the developing human fetus are unknown. For this reason
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately
Ability to understand and the willingness to sign an IRB-approved informed consent
document (either directly or via a legally authorized representative)

Exclusion Criteria

Customary bedtime later than midnight
Receiving active radiation therapy (including patients who are within 28 days of
Known and/or documented history of obstructive sleep apnea (OSA)
completing radiation therapy)
Uncontrolled behavioral or psychiatric disorder (including suicidal ideation)
Anticipated to undergo radiation therapy or require neurosurgical intervention during
Current excessive caffeine use (> 600 mg/day or > 6 cups of coffee/day)
the period of active treatment(i.e. within the next 4 months)
Contraindication to solriamfetol based on drug-drug interactions or concurrent
systemic illness that precludes drug treatment
Patients who have not recovered to < CTCAE grade 2 toxicities related to prior or
current therapy are ineligible
Exception for laboratory-based or other adverse event that is stable and not
anticipated to interfere with study related treatment must be reviewed and approved by
the study chair
Current or prior history of alcohol or drug abuse within the last 2 years as assessed
by the treating clinician
Nicotine dependence that is currently interfering with sleep based on assessment by
the treating clinician
Concurrent use of selective serotonin or norepinephrine reuptake inhibitors (e.g
selective serotonin reuptake inhibitor [SSRI], serotonin and norepinephrine reuptake
inhibitors [SNRI]) within 14 days of study enrollment
Patients who are currently taking these agents may be tapered at the direction of the
treating physician prior to study enrollment
Patients taking other medications such as narcotics, benzodiazepines, antipsychotics
antiepileptics, corticosteroids, or over-the-counter sleep aids can be enrolled. It is
recommended that the doses of these medications remain the same throughout the portion
of active study treatment unless there is a medical indication for dose adjustment
which will be determined by the treating physician
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to solriamfetol
Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
Pregnant women are excluded from this study because there is an unknown but potential
risk for adverse events in nursing infants secondary to treatment of the mother with
solriamfetol, breastfeeding should be discontinued if the mother is treated with
solriamfetol
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