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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00026897 |
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 |
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Neoplasm |
Procedure: Gamma-camera imaging Procedure: Low-risk biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | Trafficking of Indium-111-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | December 1997 |
Estimated Study Completion Date: | December 2002 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Study ID Numbers: | 980033, 98-C-0033 |
Study First Received: | November 14, 2001 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00026897 |
Health Authority: | United States: Federal Government |
Adoptive Immunotherapy Cellular Therapy Lymphocyte Migration Tumor Imaging |
Neoplasms |