TheranosticTrials.org

Clinical Trial · NCT07698899

A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)

Overview

The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

Phase 1

Contacts

Ravinder Grewal, MD (CONTACT)

grewalr@mskcc.org

212-639-2872

Sameer Farouk Sait, MBBS (CONTACT)

faroukss@mskcc.org

212-639-2153

Sameer Farouk Sait, MBBS (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07698899

Drug / Compound

DTPA-Omburtamab

Isotope(s):
Target(s):
  • B7H3
Ligand Class: Antibodies
Chelator: DTPA

Eligibility

Inclusion

  • I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.
  • Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.
  • Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.
  • Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.
  • Investigational/Biologic Agent (anti-neoplastic): Patient 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 (1 week) prior to study enrollment.

Exclusion

  • Patients with grade 4 hearing loss are excluded