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Clinical Trial Finder

Search Results

131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05064306
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sameer Farouk Sait, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Central Nervous System/Leptomeningeal Neoplasms
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Available

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Sameer Farouk Sait, MD

[email protected]

833-675-5437

Nearest Location

Site Contact

Sameer Farouk Sait, MD

[email protected]

833-675-5437


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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