LMP744 for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Sadhana Jackson, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment and Surgery
Participants receive LMP744 for 5 days, followed by surgery to remove tumor tissue
Recovery and Subsequent Treatment Cycles
Participants recover from surgery and continue receiving LMP744 monthly for up to 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Conventional Surgery or Biopsy
- LMP744
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All patients will receive LMP744 as the interventional drug along with surgery for a biopsy and a second surgery for either resection or an additional biopsy to compare the tissue pre vs. post-drug treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor
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