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

Completed · Phase 2

Conditions studied: Neoplasm

In brief

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.

Key facts

Study ID

NCT00026897

Run by

National Cancer Institute (NCI)

People needed

100

Starts

1997-12-01

Expected to finish

2002-12-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Cancer Institute (NCI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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