About this trial
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.
Eligibility criteria
Qualifiers
Participants >= 18 years of age
Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist
Karnofsky Performance Status (KPS) >60
Willing to use effective birth control method
Disqualifiers
Pregnant and/or nursing females
Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and/or poorly controlled congestive heart failure)
Social situations that would limit compliance with study requirements, such as chronic homelessness
Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)
Trial design
Treatments tested in this trial
- LMP744
- Conventional Surgery or Biopsy
Treatment groups
Locations
1Sponsors and collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Lead sponsor