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

Trafficking of Indium-111-Labeled Cultured Immune Cells in Patients Undergoing Immunotherapy for Advanced Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00026897
Enrollment
100
Registered
2001-11-15
Start date
1997-12-31
Completion date
2002-12-31
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm

Keywords

Adoptive Immunotherapy, Cellular Therapy, Lymphocyte Migration, Tumor Imaging

Brief summary

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.

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.

Interventions

PROCEDUREGamma-camera imaging
PROCEDURELow-risk biopsy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026