Actively Recruiting
Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-14
40
Participants Needed
1
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma. Eligibility: People aged 18 years or older with glioblastoma that returned after treatment. Design: Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function. Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein. LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time. Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery. Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits. Participants will continue to have telehealth visits every 3 months after they stop taking the drug.
CONDITIONS
Official Title
Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype confirmed by a neuropathologist
- Karnofsky Performance Status (KPS) greater than 60
- Willing to use an effective method of birth control during the study and for 6 months after last dose
- Agreeable to undergo craniotomy for brain biopsy and/or tumor resection
- Willing and able to appoint a durable power of attorney
- Able to provide informed consent or have a legally authorized representative provide consent if incapacitated
You will not qualify if you...
- Pregnant or nursing females
- Significant medical conditions that prevent tolerating LMP744, such as uncontrolled kidney disease or heart failure
- Social situations limiting study compliance, such as chronic homelessness
- Prior chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or 5 drug half-lives
- Additional malignancy requiring active treatment within 1 year
- Unable to undergo brain MRI
- Active autoimmune disease requiring systemic treatment within 2 years
- Cardiac disease including 2 or more heart attacks, multiple coronary procedures, elevated cardiac troponin, or ejection fraction below 45%
- Chronic low potassium (below 2.5 mmol/L)
- Known HIV infection or positive HIV test at screening
- Active Hepatitis B or C infection at screening
- Active infection needing systemic antibacterial, antiviral, or antifungal therapy within 7 days before study drug
- Prior receipt of autologous or allogeneic T cells
- Solid organ or tissue transplant recipients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sadhana Jackson, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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