Quick Search

 

 


 

 

Protocol Summary for CCBX001-048

Protocol Summary
Protocol Id: CCBX001-048
Secondary Ids:
Title: A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients with Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: Yes
IND/IDE Grantor: CBER
IND/IDE Number: BB-IND 3323
IND/IDE Serial Number: 635
Has Expanded Access?: None
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.
Detailed Description: This is a multi-center study in which 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of tellurium-derived Iodine I 131 Tositumomab. Blood Pharmacokinetics, total body clearance, tumor and organ dosimetry, and biodistribution will be assessed following administration of the dosimetric dose.
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: April 2003
Study Completion Date: April 2007
Study Completion Date Type: None
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Pharmacokinetics Study
Primary Outcomes:
  • To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma
Secondary Outcomes:
  • 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab
Conditions:
  • Non-Hodgkin's Lymphoma
Keywords:
  • Iodine I 131 Tositumomab
  • BEXXAR
  • non-Hodgkin's lymphoma
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A
Enrollment: 12
Enrollment Type: Actual
Healthy Volunteers?: No
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.