What side effects are associated with this type of intervention?

Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Surgery can lead to complications such as infection, bleeding, and neurological deficits. Radiation therapy often causes fatigue, hair loss, and skin changes at the treatment site, and can also lead to cognitive decline over time. Chemotherapy, including agents like temozolomide and lomustine, can cause side effects such as nausea, vomiting, bone marrow suppression leading to increased risk of infection, and fatigue. Investigational treatments, such as the combination of imipramine hydrochloride and lomustine, may have additional side effects including gastrointestinal disturbances, mood changes, and hematologic toxicity. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral alkylating agent that interferes with DNA replication, and bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) to reduce tumor blood supply. These treatments are often used in combination with radiotherapy. Temozolomide is typically used as the first-line treatment, while bevacizumab is used for recurrent cases. Other treatments under investigation include various targeted therapies and immunotherapies, but these have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives for Glioblastoma patients in 2024 include: 1) Antisense oligonucleotide therapy, such as Tofersen, targeting specific genetic mutations. 2) Combination therapies involving tyrosine kinase inhibitors like cabozantinib. 3) Immunotherapies, including PD-1 blockade with nivolumab. 4) mTORC1 inhibitors combined with somatostatin analogues, such as everolimus and octreotide. These therapies are being evaluated in various clinical trials and have shown potential in improving outcomes for Glioblastoma patients.

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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

Must not have

The subject has evidence of wound dehiscence

The subject has serious intercurrent illness, such as: Hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment, Non-healing wound, ulcer, or bone fracture, Untreated hypothyroidism, Unhealed rectal or peri-rectal abscess, Uncontrolled active infection, Stroke, or transient ischemic attack within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgical wound has reopened.

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I do not have serious ongoing health issues like uncontrolled high blood pressure, non-healing wounds, untreated thyroid problems, recent strokes, or active infections.

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I have recovered from side effects of previous treatments, except for hair loss, low red blood cell count, or low white blood cell count.

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I am taking certain antidepressants or pain medications and do not want to stop.

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I have a history of heart disease or issues.

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I am taking warfarin or similar drugs and cannot switch to LMWH before starting the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1750

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing the tumor burden. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, targeting the remaining cancerous tissue post-surgery. Chemotherapy, such as with the drug Lomustine, works by interfering with the DNA replication of cancer cells, preventing their growth and division. Imipramine Hydrochloride, an antidepressant, is being studied for its potential to induce cancer cell death through mechanisms that may involve the disruption of cellular metabolism and stress responses. These treatments are crucial for Glioblastoma patients as they target the aggressive and infiltrative nature of the tumor, aiming to prolong survival and improve quality of life.