40 Participants NeededMy employer runs this trial

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?

This trial explores whether a new drug, LMP744, can effectively kill tumor cells in people with glioblastoma, a type of brain cancer that often returns after standard treatments. Participants will receive LMP744 through a special port in their chest over several treatment cycles, with surgical assessments of their tumor before and after drug administration. People with recurrent glioblastoma after treatment may be eligible to join this study. Those who have undergone surgery and chemotherapy for glioblastoma but experienced a recurrence might consider this trial as an option. As a Phase 1/Phase 2 trial, the study focuses on understanding how LMP744 works in people and measuring its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this promising treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not had chemotherapy or biologic therapy within 4 weeks before starting, or 6 weeks for certain drugs like nitrosoureas and mitomycin C. If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that LMP744 is likely to be safe for humans?

Earlier studies have shown that LMP744 holds promise in the lab and in animals for treating glioblastoma, a type of brain cancer. Research indicates that LMP744 can cross the blood-brain barrier, a crucial factor in treating brain tumors. In previous human trials, researchers tested LMP744 on over 40 patients with advanced cancer. These studies found that LMP744 was generally well-tolerated, with most participants not experiencing severe side effects. The trials also aimed to determine the safest dose for humans without causing harm. While any treatment carries risks, early results suggest LMP744's safety in humans is encouraging.12345

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about LMP744 for brain cancer because it introduces a novel approach to treatment. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, LMP744 is designed to work by interfering with specific enzymes involved in DNA replication. This targeted mechanism could potentially minimize damage to healthy cells and reduce side effects. Additionally, LMP744's ability to be used alongside surgical procedures offers a unique opportunity to directly compare tissue changes before and after treatment, providing valuable insights into its effectiveness.

What evidence suggests that LMP744 might be an effective treatment for glioblastoma?

Studies have shown that LMP744 can kill tumor cells by stabilizing a part of the DNA that damages cancer cells, making it a strong candidate for treating glioblastoma, a common and aggressive brain cancer. Research indicates that LMP744 can cross into the brain and reach levels high enough to effectively kill cancer cells. Early trials with other cancers demonstrated that patients tolerate LMP744 well. These promising results suggest that LMP744 could be effective in treating glioblastoma, especially when the cancer returns after standard treatments. In this trial, all participants will receive LMP744 along with surgery for a biopsy and a second surgery for either resection or an additional biopsy to compare the tissue before and after drug treatment.12467

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?

This trial is for adults (18+) with glioblastoma that has come back after treatment. Participants must be able to consent, have a certain level of daily functioning, agree to use birth control, and be willing to undergo brain surgery or biopsy.

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.
See 6 more

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

Trial Overview

The study tests LMP744, a new drug given through a chest port for 5 days in a row each month (up to 12 months), along with standard brain tumor surgery or biopsy. The goal is to see if LMP744 can help treat recurrent glioblastoma.

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+

Citations

Phase 1 studies of the indenoisoquinolines LMP776 ... - PMC

Here, we present safety and clinical data for first-in-human clinical trials of LMP776 (NCT01051635) and LMP744 (NCT03030417) alongside ...

Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 ...

Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma.

Gibson Oncology, NIH to begin Phase 2 trials of LMP744 ...

During the Phase 2 trial, approximately 40 first-time recurrent glioblastoma patients will receive a once-a-day, one-hour infusion of LMP744 for ...

Phase 2 clinical trial tests LMP744 for the treatment of first- ...

In two Phase 1 human trials involving over 40 heavily pretreated, advanced-stage cancer patients, LMP744 proved to be well tolerated and ...

Indenoisoquinoline LMP744 in Adults With Relapsed Solid ...

Top1 inhibitors are potent anticancer agents because they stabilize the formation of the Top1-DNA cleavage complex in tumor cells, which induces DNA damage, ...

DDDR-53. Novel indenoisoquinoline inhibitors dual function ...

Human glioblastoma cells are exquisitely sensitive to LMP744 in vitro, and there is a significant survival benefit in mouse glioblastoma models ...

Gibson Oncology, NIH to begin Phase 2 trials of LMP744 ...

During the Phase 2 trial, approximately 40 first-time recurrent glioblastoma patients will receive a once-a-day, one-hour infusion of LMP744 for ...