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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026897
First Posted: November 15, 2001
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026897


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