Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ

• Status: Recruiting
• Trial end date: 2023-08-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to estimate the ability of mirtazapine to reduce depression, nausea, and vomiting, and maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Of equal importance, the investigators will monitor the tolerability of Mirtazapine in these patients over the course of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Treatments: Mirtazapine; Temozolomide

Criteria

Inclusion Criteria:

• Understand and voluntarily sign and date an informed consent document prior to any study related assessments/procedures are conducted.

• Histologically confirmed diagnosis of glioma

• No prior treatment with temozolomide TMZ

• Patient will receive temozolomide TMZ therapy as part of their standard treatment.

• Males and Females ≥18 years of age at the time of signing the informed consent document. Able to understand consent forms and study materials in English

• Willing to use approved methods of contraception for duration of study

• Karnofsy Performance Score (KPS) of at least 60

• Patients should have stopped any anti-depressant medications by standard of care at least a month before enrolling in the trial

• Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

• Prior treatment with other chemotherapy drugs for glioma

• Known hypersensitivity to Mirtazapine and 5-HT3 receptor antagonists

• Life expectancy of less than three months

• Pregnancy or breastfeeding.