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


Phase 2
N/A
N/A
Not Enrolling
Both
Neoplasm

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

980033

NCT ID:

NCT00026897

Start Date:

December 1997

Completion Date:

December 2002

Related Keywords:

  • Neoplasm
  • Adoptive Immunotherapy
  • Cellular Therapy
  • Lymphocyte Migration
  • Tumor Imaging
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892