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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 25, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

November 30, 2026

Conditions
Glioblastoma
Interventions
DRUG

Lomustine

"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."

DRUG

Imipramine 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."

Trial Locations (1)

78229

RECRUITING

Mays Cancer Center, UT Health San Antonio, San Antonio

All Listed Sponsors
lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT04863950 - Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma | Biotech Hunter | Biotech Hunter