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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064306
Expanded Access Status : Available
First Posted : October 1, 2021
Last Update Posted : July 18, 2022
Sponsor:
Collaborator:
Y-mAbs Therapeutics, Inc
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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. However, the agency has granted the drug Breakthrough Therapy Designation for the treatment of neuroblastoma with CNS metastases.

Condition or disease Intervention/treatment
Central Nervous System/Leptomeningeal Neoplasms Drug: 131I-omburtamab

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Expanded Access Use of 131I-Omburtamab Intraventricular Radioimmunotherapy for Central Nervous System/Leptomeningeal Neoplasms



Intervention Details:
  • Drug: 131I-omburtamab
    50 mCi 131I-omburtamab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to receiving treatment dose(s).

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064306


Contacts
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Contact: Sameer Farouk Sait, MD 833-675-5437 faroukss@mskcc.org
Contact: Emily Slotkin, MD 833-675-5437

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Available
New York, New York, United States, 10065
Contact: Sameer Farouk Sait, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics, Inc
Investigators
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Principal Investigator: Sameer Farouk Sait, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05064306    
Other Study ID Numbers: 21-345
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Neoplasms
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases