131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

NCT03275402 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 101
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 8

Brief Summary

Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to evaluate efficacy and safety

Conditions

Neuroblastoma; CNS Metastases; Leptomeningeal Metastases

Keywords

Radioimmunotherapy; Neuroblastoma; CNS Metastases; Leptomeningeal Metastases; Pediatric

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate

  Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method.

  3 years

Study Arms (1)

131I-omburtamab

EXPERIMENTAL

One treatment cycle of 131I-omburtamab consists of one dosimetry dose (2 mCi ) (for subjects enrolled on Version 1-7 of Protocol 101) and one treatment dose (50 mCi) for up to 2 cycles of length 5 weeks (for subjects enrolled on Version 1-7 of Protocol 101) or 4 weeks (for subject enrolled after Version 7 of Protocol 101). For Japan only, the first cycle consisted of one dosimetry dose (2 mCi ) week 1 one treatment dose (50 mCi) week 2. If eligible a second cycle of 50 mCi 131I-omburtamab was given at week 6. For subjects below 3 and 1 years of age, the treatment dose was reduced by 33% and 50%, respectively.

Biological: 131I-omburtamab

Interventions

131I-omburtamab BIOLOGICAL

Murine IgG1 monoclonal antibody radiolabeled with iodine-131

Also known as: 131I-8H9

131I-omburtamab

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal).
• Patients must be between the ages of birth and 18 years at the time of screening.
• Patients must have a life expectancy of at least 3 months.

You may not qualify if:

• Patients with primary neuroblastoma in central nervous system.
• Patients must not have an uncontrolled life-threatening infection.
• Patients must not have received cranial or spinal irradiation less than 3 weeks prior to first dose of 131I-omburtamab in this trial.
• Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrollment in this trial.
• Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must fall below Grade 3 prior to enrollment in this trial. Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.

Sponsors & Collaborators

• Y-mAbs Therapeutics: lead

Study Sites (8)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Pediatric Oncology Fukushima Medical University Hospita

Fukushima, 960-1295, Japan

Location

Hospital Sant Joan de Déu

Barcelona, 08010, Spain

Location

Related Publications (2)

• Prasad K, Serencsits BE, Chu BP, Dauer LT, Donzelli M, Basu E, Kramer K, Pandit-Taskar N. Feasibility of safe outpatient treatment in pediatric patients following intraventricular radioimmunotherapy with 131I-omburtamab for leptomeningeal disease. EJNMMI Res. 2024 Jul 31;14(1):70. doi: 10.1186/s13550-024-01127-0.

  PMID: 39083105 DERIVED

• Prasad K, Serencsits BE, Chu BP, Dauer LT, Donzelli M, Basu E, Kramer K, Pandit-Taskar N. Feasibility of safe outpatient treatment in pediatric patients following intraventricular radioimmunotherapy with 131I-omburtamab for leptomeningeal disease. Res Sq [Preprint]. 2024 Feb 28:rs.3.rs-3969388. doi: 10.21203/rs.3.rs-3969388/v1.

  PMID: 38464207 DERIVED

MeSH Terms

Conditions

Neuroblastoma; Meningeal Carcinomatosis

Interventions

omburtamab I-131

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Limitations and Caveats

The trial was terminated early due to a business strategy decision.

Results Point of Contact

• Title: Joris Wilms
• Organization: Y-mAbs Therapeutics

clinicaltrials@ymabs.com

+4570261414

Study Officials

• John Roemer, MD

  Y-mAbs Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will receive up to two cycles of intracerebroventricular 131I-omburtamab. Safety and efficacy will be investigated with short-term follow-up at 26 weeks after treatment and with long-term follow-up for up to 3 years following treatment.

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 7, 2017
• Study Start: December 11, 2018
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); ES (1); US (5); JP (1)