25 Participants Needed

Imipramine + Lomustine for Glioblastoma

MT
EG
Overseen ByEpp Goodwin
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing both surgical and non-surgical treatments to see how well they work for patients who need these types of interventions.

Will I have to stop taking my current medications?

If you are currently using SSRIs, SNRIs, MAO inhibitors, tramadol, or trazodone, you will need to taper off these medications before participating in the trial. Additionally, if you are on warfarin, you must switch to low molecular weight heparin before starting the study.

Is the combination of Imipramine and Lomustine generally safe for humans?

Lomustine has been used in combination with other treatments for brain tumors, and common side effects include changes in blood cell counts, nausea, and vomiting. These side effects can sometimes be managed with additional medications.12345

How is the drug combination of Imipramine and Lomustine unique for treating glioblastoma?

The combination of Imipramine (an antidepressant) and Lomustine (a chemotherapy drug) for glioblastoma is unique because it pairs a drug typically used for depression with a chemotherapy agent, potentially offering a novel approach to treatment. This combination is different from standard treatments that usually involve other chemotherapy drugs like temozolomide.23678

What data supports the effectiveness of the drug combination Imipramine and Lomustine for treating glioblastoma?

Research shows that lomustine, a component of the treatment, is effective in treating glioblastoma when used with other drugs like temozolomide and radiotherapy, improving long-term survival in patients.136910

Who Is on the Research Team?

William Kelly, MD | UT Health San ...

William Kelly, MD

Principal Investigator

The University of Texas Health Science Center - Mays Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My diagnosis is glioblastoma confirmed by tissue analysis.
I understand the study's risks and goals and have signed the consent form.
I am not pregnant or have agreed to use effective birth control during and 6 months after the study.
See 6 more

Exclusion Criteria

My surgical wound has reopened.
I have had a recent brain bleed or tumor bleed, confirmed by MRI or CT scan.
I do not have serious ongoing health issues like uncontrolled high blood pressure, non-healing wounds, untreated thyroid problems, recent strokes, or active infections.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Imipramine Hydrochloride and Lomustine for recurrent glioblastoma

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Imipramine Hydrochloride
  • Lomustine
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Imipramine Hydrochloride/LomustineExperimental Treatment2 Interventions

Imipramine Hydrochloride is already approved in United States, European Union, India, Brazil for the following indications:

🇺🇸
Approved in United States as Tofranil for:
  • Depression
  • Anxiety
  • Panic disorder
🇪🇺
Approved in European Union as Tofranil for:
  • Depression
  • Anxiety
  • Panic disorder
🇮🇳
Approved in India as Tofranil for:
  • Depression
  • Anxiety
  • Panic disorder
🇧🇷
Approved in Brazil as Tofranil for:
  • Depression
  • Anxiety
  • Panic disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Published Research Related to This Trial

In a study of 39 patients with newly diagnosed glioblastoma, the combination of radiotherapy and chemotherapy (lomustine and temozolomide) resulted in a median overall survival of 23.1 months, with 47.4% of patients surviving for 2 years and 18.5% for 4 years.
Patients receiving an intensified dose of chemotherapy showed significantly higher survival rates compared to those on standard doses, with some patients in the intensified group surviving over 56 months, although this came with a higher risk of severe hematotoxicity.
Long-term survival of patients with glioblastoma treated with radiotherapy and lomustine plus temozolomide.Glas, M., Happold, C., Rieger, J., et al.[2022]
In a study involving 97 patients with malignant gliomas, temozolomide (TMZ) demonstrated a significantly higher response rate (35.71%) compared to lomustine (CCNU) (9.09%), indicating its greater efficacy in treating these aggressive brain tumors.
TMZ was found to have an acceptable safety profile, with common side effects being mild nausea and vomiting, suggesting it could be a preferred chemotherapy option for patients with refractory malignant brain gliomas.
[A multicenter randomized controlled study of temozolomide in 97 patients with malignant brain glioma].Qian, ZZ., Wang, HQ., Liu, XM., et al.[2018]
In a study of 31 adult patients with newly diagnosed glioblastoma, the combination of lomustine, temozolomide (TMZ), and involved-field radiotherapy showed promising efficacy, with a median overall survival time of 22.6 months and a 2-year survival rate of 44.7%.
The treatment had acceptable toxicity levels, with 16% of patients experiencing severe hematotoxicity, and the presence of MGMT gene-promoter methylation in tumors was linked to longer progression-free survival and overall survival.
Phase II trial of lomustine plus temozolomide chemotherapy in addition to radiotherapy in newly diagnosed glioblastoma: UKT-03.Herrlinger, U., Rieger, J., Koch, D., et al.[2018]

Citations

Long-term survival of patients with glioblastoma treated with radiotherapy and lomustine plus temozolomide. [2022]
[A multicenter randomized controlled study of temozolomide in 97 patients with malignant brain glioma]. [2018]
Phase II trial of lomustine plus temozolomide chemotherapy in addition to radiotherapy in newly diagnosed glioblastoma: UKT-03. [2018]
Nitrosoureas in the Management of Malignant Gliomas. [2018]
Mebendazole plus lomustine or temozolomide in patients with recurrent glioblastoma: A randomised open-label phase II trial. [2022]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Results of hyperfractionated radiation therapy used in combination with lomustin in malignant gliomas of the brain]. [2018]
Prevention of emesis in patients receiving cytotoxic drugs by GR38032F, a selective 5-HT3 receptor antagonist. [2019]
[Effective measures against side effects by increasing ACNU dose for malignant glioma: effects on digestive organs]. [2013]
Carboplatin and teniposide concurrent with radiotherapy in patients with glioblastoma multiforme: a phase II study. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Neuro-Oncology Working Group 01 trial of nimustine plus teniposide versus nimustine plus cytarabine chemotherapy in addition to involved-field radiotherapy in the first-line treatment of malignant glioma. [2013]
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