LMP744 for Brain Cancer

SJ
Overseen BySadhana Jackson, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SJ

Sadhana Jackson, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to appoint someone to make decisions for me if needed.
I can give consent for myself or have someone legally allowed to do so for me.
I have recurrent glioblastoma confirmed by tissue testing as IDH-wildtype.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Initial Treatment and Surgery

Participants receive LMP744 for 5 days, followed by surgery to remove tumor tissue

2 weeks
5 visits (in-person)

Recovery and Subsequent Treatment Cycles

Participants recover from surgery and continue receiving LMP744 monthly for up to 12 cycles

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Telehealth visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional Surgery or Biopsy
  • LMP744

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Arm AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials
1,403
Recruited
655,000+