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Tricyclic Antidepressant

Imipramine + Lomustine for Glioblastoma

Phase 2

Recruiting

Led By William Kelly, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject has histologically confirmed glioblastoma

The subject is at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will study whether a new treatment is effective for people with a certain medical condition. Some people in the trial will have surgery as part of the new treatment, and some will not.

Who is the study for?

Adults with confirmed glioblastoma who've had prior standard treatment and are now seeing progression. They must be in relatively good health (ECOG ≤ 2), have a life expectancy over 3 months, and proper organ function. Participants need to agree to contraception use and cannot be pregnant or breastfeeding. Exclusions include those unable to undergo MRI, recent users of certain anti-epileptic drugs, individuals with serious illnesses like uncontrolled hypertension or infections, history of cardiac disease, or those on specific medications.Check my eligibility

What is being tested?

The trial is testing the combination of Imipramine Hydrochloride and Lomustine in patients with recurrent glioblastoma. It's an open-label study meaning everyone knows what treatment they're getting. There are two groups: one undergoing surgery plus the drug therapy and another just receiving the drug therapy without surgery.See study design

What are the potential side effects?

Potential side effects may include nausea from Lomustine; mood changes due to Imipramine Hydrochloride; blood count issues affecting immunity; liver or kidney function changes; fatigue; digestive problems; increased risk for infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is glioblastoma confirmed by tissue analysis.

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I am 18 years old or older.

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My kidney function is normal, based on my creatinine levels.

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My blood counts are within the required ranges without needing help.

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My liver function tests are within the required range.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer progressed after treatment with radiation and temozolomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Imipramine Hydrochloride/LomustineExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lomustine

2008

Completed Phase 3

~1540

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,385 Total Patients Enrolled

4 Trials studying Glioblastoma

139 Patients Enrolled for Glioblastoma

William Kelly, MDPrincipal InvestigatorThe University of Texas Health Science Center - Mays Cancer Center

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Glioblastoma

40 Patients Enrolled for Glioblastoma

Media Library

Imipramine Hydrochloride (Tricyclic Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04863950 — Phase 2

Glioblastoma Research Study Groups: Imipramine Hydrochloride/Lomustine

Glioblastoma Clinical Trial 2023: Imipramine Hydrochloride Highlights & Side Effects. Trial Name: NCT04863950 — Phase 2

Imipramine Hydrochloride (Tricyclic Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04863950 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what reason is Imipramine Hydrochloride most commonly prescribed?

"Imipramine Hydrochloride can be used to effectively treat hodgkin disease, brain disorders, and attention deficit hyperactivity disorder (ADHD)."

Answered by AI

Could you give us an estimate of how many people are participating in this particular clinical trial?

"Yes, the online information for this clinical trial on clinicaltrials.gov confirms that it is ongoing and looking for participants. The trial was first posted on 5/25/2022 and most recently updated on 7/21/2022. They are searching for 25 participants from 1 location."

Answered by AI

Could you please describe the risks associated with Imipramine Hydrochloride?

"Imipramine Hydrochloride is a Phase 2 medication, which means that while there is data supporting its safety, there is none yet affirming its efficacy."

Answered by AI

Are there any more positions available for participants in this experiment?

"That is correct, the listing on clinicaltrials.gov says this research is actively looking for subjects. The trial was posted on May 25th, 2022 and updated as recently as July 21st, 2022. They are hoping to find 25 individuals total from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

William Kelly 2022. "Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04863950.

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