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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026897
First received: November 14, 2001
Last updated: March 3, 2008
Last verified: December 2002
  Purpose

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.


Condition Intervention Phase
Neoplasm
Procedure: Gamma-camera imaging
Procedure: Low-risk biopsy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Trafficking of Indium-111-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: December 1997
Estimated Study Completion Date: December 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

All patients will be 18 years of age or older.

All patients will be enrolled in NCI-approved intramural immunotherapy protocol in which immune cells are adoptively administered to treat advanced cancer.

EXCLUSION CRITERIA

Patients who are receiving less than 3x10(9) cells in transfer will be excluded.

Impaired patients who are unable to give valid informed consent will also be excluded.

Patients who are pregnant will be excluded.

All other exclusion criteria stated in the parent immunotherapy protocol.

Patients who are HIV-infected.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026897

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00026897     History of Changes
Other Study ID Numbers: 980033, 98-C-0033
Study First Received: November 14, 2001
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adoptive Immunotherapy
Cellular Therapy
Lymphocyte Migration
Tumor Imaging

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014