NCT00026897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2002

First QC Date

November 14, 2001

Last Update Submit

March 3, 2008

Conditions

Neoplasm

Keywords

Adoptive ImmunotherapyCellular TherapyLymphocyte MigrationTumor Imaging

Interventions

Gamma-camera imagingPROCEDURE
Low-risk biopsyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • Patients who are HIV-infected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 3486223BACKGROUND

  • 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.

    PMID: 2953816BACKGROUND

  • 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. doi: 10.1056/NEJM198812223192527.

    PMID: 3264384BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

December 1, 1997

Study Completion

December 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-12

Locations

US(1)