Central Nervous System/Leptomeningeal NeoplasmsNCT05064306
131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults
A study testing 131I-omburtamab in people with Central Nervous System/Leptomeningeal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The researchers are doing this study to provide access to treatment with 131I-omburtamab for children and young adults who have CNS/leptomeningeal neoplasms. 131I-omburtamab is an investigational drug; the FDA has not approved it to treat this cancer or any other disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System/Leptomeningeal Neoplasms
- What is being tested?
- 131I-omburtamab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of an embryonal malignancy (including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, PNET, rhabdomyosarcoma, Ewing's sarcoma, Wilm's tumor, hepatoblastoma) other non-embryonal tumors must have histologic confirmation of B7-H3 reactivity.
- Patients must have a diagnosis of CNS/ leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists or a recurrent brain tumor with a predilection for leptomeningeal dissemination (i.e. PNET, rhabdoid tumor).
- Chemotherapy:
- °Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days (3 weeks) prior to receiving treatment dose(s).
- Biologic or investigational agent (anti-neoplastic):
- Patients who are currently on biological (small molecule inhibitors such as ALK inhibitors, ROS inhibitors or MEK inhibitors etc.) or investigational agents that are considered non-myelosuppressive can continue treatment but should have recovered from any acute toxicity potentially related to the agent.
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- Patients may be treated if they received one prior treatment dose with 131I-omburtamab
- Monoclonal antibody treatment and agents with known prolonged half-lives:
- Patients must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 21 days prior to enrollment.
- Monoclonal antibody treatment and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to receiving treatment dose(s).
- Neurologic Status:
- Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.
- Patients with seizure disorders may be enrolled if seizures are controlled.
- Performance Status:
- °Karnofsky Performance Scale (KPS for > 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 2 weeks prior to study enrollment must be ≥ 50%. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Adequate bone marrow function defined as:
- Peripheral absolute neutrophil count (ANC) ≥ 0.5x 10^9/ L (must not have received G-CSF within the 7 days prior to enrollment or pegfilgrastim within the 14 days prior to enrollment)
- Platelet count ≥ 50 x 10^9/ L (unsupported, defined as no platelet transfusion within 7 days prior to study enrollment)
- Intraventricular Access Device °Protocol treatment with radioimmunotherapy (131I-omburtumab) will require the presence of an appropriate intraventricular access device (e.g.,programmable ventriculoperitoneal [VP] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to Radioimmunotherapy.
- Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt before treatment with 131I-omburtumab.
- Both pediatric and adult patients of any age are eligible.
- Patients may have active malignancy outside the central nervous system.
- Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least week prior to enrollment
- Signed informed consent and assent when appropriate indicating awareness of the investigational nature of this study.
Who cannot join
- Patients with obstructive or symptomatic communicating hydrocephalus
- Patients with an uncontrolled life-threatening infection
- Patients who are pregnant: negative pregnancy test is required for all women of childbearing age, and appropriate contraception is required during the study period.
- Patients who have received cranial or spinal irradiation less than 3 weeks prior to first dose
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Expanded Access Use of 131I-Omburtamab Intraventricular Radioimmunotherapy for Central Nervous System/Leptomeningeal Neoplasms
The researchers are doing this study to provide access to treatment with 131I-omburtamab for children and young adults who have CNS/leptomeningeal neoplasms. 131I-omburtamab is an investigational drug; the FDA has not approved it to treat this cancer or any other disease. However, the agency has granted the drug Breakthrough Therapy Designation for the treatment of neuroblastoma with CNS metastases.
- Being tested
- 131I-omburtamab
- Keywords
- 131I-omburtamab, neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, PNET, rhabdomyosarcoma, Ewing's sarcoma, Wilm's tumor, hepatoblastoma, non-embryonal tumors, histologic confirmation of B7-H3 reactivity, 21-345
- Medical subject headings
- Meningeal Neoplasms, Neuroblastoma, Medulloblastoma, Rhabdoid Tumor, Pinealoma, Retinoblastoma, Neuroectodermal Tumors, Primitive, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-omburtamabDrug
50 mCi 131I-omburtamab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System/Leptomeningeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Y-mAbs Therapeutics
- Responsible party
- Sponsor
- Investigators
- Sameer Farouk Sait, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064306
- Sponsor's protocol ID
- 21-345
- Status last verified
- Jul 2025
- First submitted
- 29 Sep 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of 131I-Omburtamab Intraventricular Radioimmunotherapy for Central Nervous System/Leptomeningeal Neoplasms
- ClinicalTrials.gov ID
- NCT05064306
- Acronym / sponsor ID
- 21-345
- Keywords
- 131I-omburtamab, neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, PNET, rhabdomyosarcoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Y-mAbs Therapeutics
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to provide access to treatment with 131I-omburtamab for children and young adults who have CNS/leptomeningeal neoplasms. 131I-omburtamab is an investigational drug; the FDA has not approved it to treat this cancer or any other disease. However, the agency has granted the drug Breakthrough Therapy Designation for the treatment of neuroblastoma with CNS metastases.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must have a histologically confirmed diagnosis of an embryonal malignancy (including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, PNET, rhabdomyosarcoma, Ewing's sarcoma, Wilm's tumor, hepatoblastoma) other non-embryonal tumors must have histologic confirmation of B7-H3 reactivity.
- Patients must have a diagnosis of CNS/ leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists or a recurrent brain tumor with a predilection for leptomeningeal dissemination (i.e. PNET, rhabdoid tumor).
- Chemotherapy:
- °Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days (3 weeks) prior to receiving treatment dose(s).
- Biologic or investigational agent (anti-neoplastic):
Key exclusion criteria (4 listed)
- Patients with obstructive or symptomatic communicating hydrocephalus
- Patients with an uncontrolled life-threatening infection
- Patients who are pregnant: negative pregnancy test is required for all women of childbearing age, and appropriate contraception is required during the study period.
- Patients who have received cranial or spinal irradiation less than 3 weeks prior to first dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 131I-omburtamab50 mCi 131I-omburtamab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Farouk Sait, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 131I-omburtamab in people with Central Nervous System/Leptomeningeal Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.