XCancer

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

Description:

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)

Government Study Link:

NCT07698899 - Click here to see study on

ClinicalTrials.gov

DTPA-Omburtamab

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