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New treatment option for Glioblastoma
Official title Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT04863950
What this study is testing
What is Lomustine?
Lomustine is an investigational medicine, being studied as a potential treatment for glioblastoma.
Also referred to as Gleostine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- 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
You likely can't join if
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first...
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. people with resolving...
- 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...
- The subject has evidence of wound dehiscence.
See the full eligibility criteria
- 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 people must agree to use effective means of...
- 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. people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.