Official Title
Expanded Access Use of 131I-Omburtamab Intraventricular Radioimmunotherapy for Central Nervous System/Leptomeningeal Neoplasms
Brief Summary

The researchers are doing this study to provide access to treatment with 131I-omburtamabfor children and young adults who have CNS/leptomeningeal neoplasms. 131I-omburtamab isan investigational drug; the FDA has not approved it to treat this cancer or any otherdisease. However, the agency has granted the drug Breakthrough Therapy Designation forthe treatment of neuroblastoma with CNS metastases.

Detailed Description

Not Provided

Available
Treatment IND/Protocol
Central Nervous System/Leptomeningeal Neoplasms

Drug: 131I-omburtamab

50 mCi 131I-omburtamab

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Memorial Sloan Kettering Cancer Center
New York, New York, United States

Investigator: Sameer Farouk Sait, MD

Contacts

Sameer Farouk Sait, MD
833-675-5437
faroukss@mskcc.org

Emily Slotkin, MD
833-675-5437

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

Y-mAbs Therapeutics
NCT Number
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
MeSH Terms
Neoplasms
Meningeal Neoplasms