GlioblastomaPhase 2NCT04863950
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
A Phase 2 study testing Lomustine and Imipramine Hydrochloride in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Lomustine and Imipramine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
Epp Goodwin, 210-450-1000
William Kelly, MD
About this study
Official title: A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.
- Conditions
- Glioblastoma
- Being tested
- Lomustine, Imipramine Hydrochloride
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LomustineDrug
Also called Gleostine
For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced.
For non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1.
For both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks.
Imipramine HydrochlorideDrug
Also called Trofranil
For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days.
For non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days.
| Study group | Role | What they receive |
|---|---|---|
| Imipramine Hydrochloride/Lomustine | Experimental | Not described Receives: Drug: Lomustine; Drug: Imipramine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start25 May 2022
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Kelly, The University of Texas Health Science Center at San Antonio
- Investigators
- William Kelly, MD, Principal investigator, The University of Texas Health Science Center - Mays Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863950
- Sponsor's protocol ID
- CTMS# 20-0148
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2021
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04863950
- Acronym / sponsor ID
- CTMS# 20-0148
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imipramine Hydrochloride/Lomustine | Experimental | Drug: Lomustine, Drug: Imipramine Hydrochloride |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LomustineAlso: GleostineFor surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced. For non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1. For both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks. | Drug | Imipramine Hydrochloride/Lomustine |
| Imipramine HydrochlorideAlso: TrofranilFor the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days. For non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days. | Drug | Imipramine Hydrochloride/Lomustine |
Primary outcome
Progression Free Survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Kelly, MD principal investigator
The University of Texas Health Science Center - Mays Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lomustine and Imipramine Hydrochloride in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Epp Goodwin (210 450 5798, goodwine@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.