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

Purpose

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
Neoplasm	Procedure: Gamma-camera imaging Procedure: Low-risk biopsy	Phase II

MedlinePlus related topics:

Cancer Nuclear Scans

U.S. FDA Resources

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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	100
Study Start Date:	December 1997
Estimated Study Completion Date:	December 2002

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026897

Locations


United States, Maryland
	National Cancer Institute (NCI)
	Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Publications:

Shu S, Chou T, Rosenberg SA. In vitro sensitization and expansion with viable tumor cells and interleukin 2 in the generation of specific therapeutic effector cells. J Immunol. 1986 May 15;136(10):3891-8.

Shu SY, Chou T, Rosenberg SA. Generation from tumor-bearing mice of lymphocytes with in vivo therapeutic efficacy. J Immunol. 1987 Jul 1;139(1):295-304.

Rosenberg SA, Packard BS, Aebersold PM, Solomon D, Topalian SL, Toy ST, Simon P, Lotze MT, Yang JC, Seipp CA, et al. Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. A preliminary report. N Engl J Med. 1988 Dec 22;319(25):1676-80.

Study ID Numbers:	980033, 98-C-0033
First Received:	November 14, 2001
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00026897
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Adoptive Immunotherapy

Cellular Therapy

Lymphocyte Migration

Tumor Imaging

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00026897