Study of Imipramine Hydrochloride and Lomustine for Recurrent Glioblastoma
This study is testing a combination of two drugs, Imipramine Hydrochloride and Lomustine, for people with recurrent glioblastoma (a type of brain cancer). You may be able to join if you are at least 18 years old, have glioblastoma that has returned after standard treatment, and meet other specific health requirements. The researchers want to see if this drug combination can help people live longer without their cancer getting worse. This is measured at 6 months. The current status of this study is unclear, and it plans to enroll 25 participants.
- Study design
- This is a single-center, open-label, single-arm study, meaning all participants receive the study treatments. It includes both surgical and non-surgical groups.
- What's involved
- For surgical patients, Imipramine Hydrochloride is started before surgery and Lomustine is started within 6 weeks after surgery. Specific details about visits or tests are not provided.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure how long participants live without their cancer progressing, which is assessed at 6 months.
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NCT04863950
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
Recruiting
PHASE2All AgesInterventionalTreatmentThe University of Texas Health Science Center at San AntonioInvestigator-initiated
~25 participants
Updated 2025-08-27 on ClinicalTrials.gov
What's tested:LomustineImipramine Hydrochloride
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival
Measured over 6 months
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- William Kelly, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center - Mays Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
The subject is at least 18 years of age
The subject has the ability to understand the purposes and risks of the study and to have signed a written informed consent form approved by the investigator's IRB/Ethics Committee
The subject has histologically confirmed glioblastoma
The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy
The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
The subject has a life expectancy of at least 3 months
The subject has acceptable liver function:
Bilirubin ≤ 1.5 times upper limit of normal
AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN)
The subject has acceptable renal function:
Serum creatinine ≤ULN
The subject has acceptable hematologic status (without hematologic support):
ANC (absolute neutrophil count) ≥1500 cells/uL
Platelet count ≥100,000/uL
Hemoglobin ≥9.0 g/dL
All women of childbearing potential (not surgically sterilized or at least 1 year post-menopausal) must have a negative serum pregnancy test. Additionally, male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.
Exclusion
The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
The subject is unable to undergo MRI scan (eg, has pacemaker).
The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
The subject has evidence of wound dehiscence.
The subject is pregnant or breast-feeding.
The subject has a history of cardiac disease, including arrhythmia, conduction abnormality, congenital prolonged QT syndrome, myocardial infarction, unstable angina pectoris or congestive heart failure.
A prolonged QTc rhythm noted during initial ECG \>480 ms.
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
The subject has received any of the following prior anticancer therapy:
Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
Non-bevacizumab systemic therapy (including investigational agents and small- molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug
Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
Prior treatment with carmustine wafers
Any current psychosis, uncontrolled mood disorder (as assessed by investigator) or suicidal ideation. Additionally, current or history of bipolar disorder is excluded.
Patients currently using SSRI, SNRI, MAO inhibitors, tramadol or trazodone who are unwilling to undergo taper.
What this trial measures
- Progression Free Survival6 months