24 Participants NeededMy employer runs this trial

177Lu-DTPA-Omburtamab for Brain Cancer

Recruiting at 6 trial locations
SF
RG
Overseen ByRavinder Grewal, MD
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
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 177Lu-DTPA-omburtamab, a targeted radiotherapy, is safe for children and teens with certain brain cancers that haven't responded to other treatments. Researchers will test different doses to determine the safest amount. The trial targets individuals with medulloblastoma or similar cancers that have spread to the brain or spinal cord and have not responded to standard treatments. Participants should have stable symptoms and be able to manage daily activities, even if they require some assistance, such as using a wheelchair. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Is there any evidence suggesting that 177Lu-DTPA-Omburtamab is likely to be safe for humans?

Research shows that 177Lu-DTPA-omburtamab remains in the early stages of testing for treating brain cancer in children and teenagers. As this is an early phase trial, the primary goal is to assess the treatment's safety.

Although data is limited, similar antibody-based treatments have shown promise. For instance, earlier trials with a related drug, 131 I-omburtamab, reported side effects such as tiredness and low blood cell counts, but these were generally manageable.

It is important to note that this trial is just beginning to evaluate safety, so more detailed safety information will emerge as the study progresses.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about 177Lu-DTPA-Omburtamab because it offers a novel approach to treating brain cancer by targeting cancer cells with precision. Unlike traditional treatments like surgery, radiation, or chemotherapy, which can affect both healthy and cancerous cells, this treatment uses a radioactive molecule, 177Lu-DTPA, that specifically binds to tumor cells. This targeted action helps to deliver radiation directly to the cancer, potentially minimizing damage to surrounding healthy brain tissue. Additionally, the treatment is being explored in multiple dose levels, ranging from 25 mCi to 100 mCi, allowing researchers to determine the most effective and safe dosage for patients.

What evidence suggests that 177Lu-DTPA-Omburtamab might be an effective treatment for brain cancer?

Research has shown that 177Lu-DTPA-Omburtamab targets tumors with the B7-H3 protein. This treatment delivers radiation directly to cancer cells, potentially improving outcomes for children with brain cancer. Studies have found that similar treatments can increase survival rates by targeting specific tumor markers. Early results suggest this method might be effective for aggressive cancers like medulloblastoma, which often spread to the central nervous system (CNS). Although detailed human data on this specific treatment remains limited, the targeted approach shows promise. Participants in this trial will receive varying doses of 177Lu-DTPA-Omburtamab to evaluate its effectiveness and safety.12356

Who Is on the Research Team?

SF

Sameer Farouk Sait, MBBS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and teens who have brain cancer (like medulloblastoma) or cancer that has spread to the brain or spinal cord, especially if their disease has come back or hasn't responded to other treatments.

Inclusion Criteria

My neurological symptoms have been stable for at least 7 days and my seizures are controlled.
My liver tests are within the acceptable range for this study.
I have or am willing to get an intraventricular access device before treatment.
See 11 more

Exclusion Criteria

I have obstructive or symptomatic communicating hydrocephalus.
I am not pregnant and will use birth control for 3 months after treatment.
I do not have an uncontrolled, life-threatening infection.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab, each cycle lasting 28 days

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-DTPA-Omburtamab

Trial Overview

The study is testing a new treatment called 177Lu-DTPA-omburtamab, which delivers targeted radiation directly to cancer cells in the brain or central nervous system. The main goal is to see if this treatment is safe.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Dose Level 4: 100 mCiExperimental Treatment1 Intervention
Group II: Dose Level 3: 75 mCiExperimental Treatment1 Intervention
Group III: Dose Level 2: 50 mCiExperimental Treatment1 Intervention
Group IV: Dose Level 1: 25 mCiExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Y-mAbs Therapeutics

Industry Sponsor

Trials
26
Recruited
1,600+

Citations

1.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/api/117541/

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