NCT00026897

Trafficking of Indium-III-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

Trafficking of Indium-111-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in some patients for enumeration of radiolabeled cells. End-points will be tumor and normal organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.

Detailed description

Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in some patients for enumeration of radiolabeled cells. End-points will be tumor and normal organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.

Conditions

• Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Gamma-camera imaging
PROCEDURE	Low-risk biopsy

Timeline

• Start date: 1997-12-01
• Completion: 2002-12-01
• First posted: 2001-11-15
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States