Study on New Drug LMP744 for Treating Recurrent Glioblastoma

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Sponsor score: 0

ClinicalTrials ID:NCT07416188

Provider View

This clinical trial is testing a new drug, LMP744, to see if it can help treat glioblastoma, a type of brain cancer that often returns after initial treatment. The study aims to find out if LMP744 can effectively kill tumor cells in adults whose cancer has come back.

Patient Parameters

Program Overview

Glioblastoma is a common and aggressive brain cancer in adults. Even after surgery, radiation, and chemotherapy, this cancer can return and is often difficult to treat. Researchers are testing a new drug called LMP744 to see if it can help kill glioblastoma tumor cells. The study involves adults aged 18 and older whose glioblastoma has returned after treatment. Participants will undergo a series of procedures, including tumor biopsies, receiving the study drug through a central line, and follow-up visits to monitor their health and the drug's effects.

Description

Participants in this study will first have a small sample of their tumor removed (biopsy) to confirm the return of glioblastoma. This will help doctors understand the cancer better. After confirmation, participants will receive the study drug, LMP744, through a central line—a small tube placed in a vein in the chest—for five days. This allows the drug to be given without repeated needle sticks.

After receiving LMP744, participants will have surgery to remove as much of the tumor as possible. They will stay in the clinic until they recover from the surgery and then continue their recovery at home. Once recovered, participants will return to the clinic monthly to receive the study drug for five days in a row, for up to 12 months. During these visits, doctors will perform blood tests, heart function tests, and imaging scans to monitor the participants' health and the drug's effects.

The study aims to see if LMP744 can reduce the size of the tumor or stop it from growing. Researchers will also look at how long participants live without the cancer getting worse and their overall survival. Additionally, the study will assess the impact of LMP744 on participants' quality of life and explore any changes in the tumor at the molecular level.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with recurrent glioblastoma, confirmed by a specialist.
  • Able to perform daily activities with some effort (Karnofsky Performance Status over 60).
  • Willing to use effective birth control during the study and for six months after the last dose of LMP744.
  • Agree to undergo brain surgery for tumor biopsy or removal.
  • Able to appoint someone to make medical decisions if needed.
  • Able to provide informed consent or have a representative do so if incapacitated.

Exclusion Criteria

  • Pregnant or nursing women, due to potential risks to the baby.
  • Significant medical conditions that cannot be controlled and may affect the ability to tolerate the study drug.
  • Social situations that may prevent following study requirements, like chronic homelessness.
  • Recent chemotherapy or biologic therapy within the last four to six weeks.
  • Another active cancer diagnosed or treated within the last year.
  • Unable to have an MRI scan of the brain.
  • Active autoimmune disease requiring treatment within the last two years.
  • Certain heart conditions, such as multiple heart attacks or procedures.
  • Low potassium levels in the blood.
  • HIV positive or active Hepatitis B or C infection.
  • Active infection needing treatment within seven days before starting the study drug.
  • Previous recipients of certain cell or organ transplants.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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