RecruitingPhase 2NCT04863950

Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

25 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

Summary

This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — imipramine (an older antidepressant) and lomustine (a chemotherapy drug) — in people with glioblastoma (an aggressive brain tumor) that has come back after standard treatment. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with glioblastoma confirmed by pathology - Your tumor has progressed or returned after completing standard treatment (radiation plus temozolomide chemotherapy) - You are in adequate general health to receive treatment **You may NOT be eligible if...** - Your tumor has not been previously treated with standard therapy - Your performance status is too poor (ECOG too high) to safely receive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLomustine

For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced. For non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1. For both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks.

DRUGImipramine Hydrochloride

For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days. For non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days.