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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Neoplasm

Treatments: Procedure: Low-risk biopsy; Procedure: Gamma-camera imaging

Study type: Interventional

Funder types: NIH

Identifiers

NCT00026897

980033

98-C-0033

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.