Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509301
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2007-07-27
Brief Title:
Safety Radiation Distribution Study of Cotara in Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Peregrine Pharmaceuticals
Organization:
Peregrine Pharmaceuticals
Study Overview
Official Title:
Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1B MAb Cotara for the Treatment of Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Cotara is an experimental new treatment that links a radioactive isotope iodine 131 to a targeted monoclonal antibody This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues Cotara thus literally destroys the tumor from the inside out This may be an effective treatment for glioblastoma multiforme a malignant type of brain cancer
PURPOSE This trial is studying the safety and radiation distribution of Cotara in patients with recurrent glioblastoma multiforme
PURPOSE This trial is studying the safety and radiation distribution of Cotara in patients with recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
To confirm the dose limiting toxicities DLT and maximum tolerated dose MTD of 131I-chTNT-1B MAb Cotara when given as a single 25 hour interstitial infusion in patients with recurrent GBM
To characterize the biodistribution and radiation dosimetry of Cotara
OUTLINE
This is an open-label dose escalation study of Cotara
All patients will receive 3 mCi of Cotara for biodistribution and radiation dosimetry purposes In addition patients will receive escalating therapeutic dose levels of Cotara for confirmation of the maximum tolerated dose MTD After completion of study treatment patients are followed for a minimum of 12 weeks and until disease progression
Primary
To confirm the dose limiting toxicities DLT and maximum tolerated dose MTD of 131I-chTNT-1B MAb Cotara when given as a single 25 hour interstitial infusion in patients with recurrent GBM
To characterize the biodistribution and radiation dosimetry of Cotara
OUTLINE
This is an open-label dose escalation study of Cotara
All patients will receive 3 mCi of Cotara for biodistribution and radiation dosimetry purposes In addition patients will receive escalating therapeutic dose levels of Cotara for confirmation of the maximum tolerated dose MTD After completion of study treatment patients are followed for a minimum of 12 weeks and until disease progression
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