177Lu-DTPA-Omburtamab for Brain Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab, each cycle lasting 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
100 mCi 177Lu- DTPA-omburtamab
75 mCi 177Lu- DTPA-omburtamab
50 mCi 177Lu- DTPA-omburtamab
25 mCi 177Lu- DTPA-omburtamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Y-mAbs Therapeutics
Industry Sponsor
Citations
177lu-dtpa-omburtamab
Abexperimental Clinical trial activity 2 trials. Earliest trial started Apr 29, 2020. Indications Studied for Medulloblastoma · Neoplasm Metastasis. Chemistry ...
Y-mAbs' 177Lu-omburtamab-DTPA for the Treatment of ...
177Lu-omburtamab-DTPA, a monoclonal B7-H3 antibody ・ is currently in a multicenter Phase 1 clinical trial in pediatric patients ・ positive ...
3.
researchgate.net
researchgate.net/publication/26736814_Current_Treatment_Strategies_for_Brain_Metastasis_and_Complications_From_Therapeutic_TechniquesCurrent Treatment Strategies for Brain Metastasis and ...
yielding a median survival time of only 3 to 6 months of radiation sensitizers and blood– brain barrier penetrating cytotoxics such as ...
You are not alone on this journey...
The five-story building will be the largest translational research center in the world singularly focused on accelerating brain tumor drug ...
Y-mAbs' 177Lu-omburtamab-DTPA for the Treatment of ...
177Lu-omburtamab-DTPA for the treatment of medulloblastoma. , which targets tumors that express B7-H3.
Updated results from pivotal Trial 101 | Request PDF
In a completed phase II/III trial testing 131 I-omburtamab in patients with neuroblastoma with brain metastases or LMD, 6-month CNS PFS was 75% ...
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