Actively Recruiting

Phase 2
All Genders
NCT04863950

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-08-27

25

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Ability to understand the study and provide written informed consent
  • Histologically confirmed glioblastoma
  • Disease progression after standard radiation and temozolomide treatment
  • ECOG performance status of 2 or less
  • Life expectancy of at least 3 months
  • Acceptable liver function: bilirubin ≤ 1.5 times upper limit of normal, AST and ALT ≤ 3 times upper limit of normal
  • Acceptable kidney function: serum creatinine ≤ upper limit of normal
  • Acceptable blood counts without support: ANC ≥ 1500 cells/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9.0 g/dL
  • Women of childbearing potential must have negative pregnancy test and agree to effective contraception, as must male participants
Not Eligible

You will not qualify if you...

  • Use of warfarin or other coumarin anticoagulants without ability to switch to low molecular weight heparin
  • Evidence of acute brain or tumor bleeding on MRI or CT (except resolving or minor hemorrhage)
  • Inability to undergo MRI (e.g., pacemaker)
  • Use of enzyme-inducing anti-epileptic drugs within 14 days prior to study
  • Not recovered to grade 1 or better from prior adverse events except alopecia, anemia, lymphopenia
  • Presence of wound dehiscence
  • Pregnant or breastfeeding
  • History of cardiac disease including arrhythmia, prolonged QT syndrome, heart attack, unstable angina, or heart failure
  • Prolonged QTc interval > 480 ms on ECG
  • Serious illnesses including uncontrolled hypertension, non-healing wounds, untreated hypothyroidism, abscesses, active infections, recent stroke or transient ischemic attack
  • Prior treatments such as non-standard radiation, recent systemic therapies including biologics or chemotherapy within specified timeframes, or carmustine wafers
  • Current psychosis, uncontrolled mood disorder, suicidal ideation, or bipolar disorder history
  • Current use of certain antidepressants or pain medications without willingness to taper

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

E

Epp Goodwin

CONTACT

M

Maggie Tomasini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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