NCT00089245

Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous system/leptomeningeal (CNS/LM) malignancies.

Detailed description

This is a phase I study, where the purpose is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.

Conditions

• Brain and Central Nervous System Tumors
• Neuroblastoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	Iodine I 131 MOAB 8H9	Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.
DRUG	Iodine I 131 MOAB 8H9	The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.

Timeline

• Start date: 2004-02-05
• Primary completion: 2022-02-02
• Completion: 2022-02-02
• First posted: 2004-08-05
• Last updated: 2023-12-26

Locations

1 site across 1 country: United States