Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089245
Status:
TERMINATED
Last Update Posted:
2023-12-26
First Post:
2004-08-04
Brief Title:
Radiolabeled MAB Therapy in Patients With Refractory Recurrent or Advanced CNS or Leptomeningeal Cancer
Sponsor:
Y-mAbs Therapeutics
Organization:
Y-mAbs Therapeutics
Study Overview
Official Title:
Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous SystemLeptomeningeal Neoplasms
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate business decision No safety or efficacy concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous systemleptomeningeal CNSLM 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-03133 | OTHER | Memorial Sloan Kettering Cancer Center | None |