Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma

March 21, 2017 updated by: Mayo Clinic

In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy

RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma tumors may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.

PURPOSE: This study is measuring radiolabeled white blood cells in patients with non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the number of indium In 111-labeled peripheral blood mononuclear cells (PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.
  • Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these patients.
  • Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking of PBMCs vs PMNLs in these patients.
  • Gather important data regarding the inter- and intra-patient variability of effector cell trafficking into these tumors.
  • Assess the relationship between response at 8-12 weeks and the magnitude of baseline effector cell trafficking or the magnitude of post-rituximab effector cell trafficking in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.

  • Group I: Patients receive autologous indium In 111 (^111In)-labeled peripheral blood mononuclear cells on day 0.
  • Group II: Patients receive autologous ^111In-labeled polymorphonuclear leukocytes on day 0.

In both groups, patients undergo blood collection on day 0. Patients then undergo full-body single-photon emission-computed tomography (SPECT) scan 4 hours after cell infusion and on day 2. The labeling and imaging process may be repeated after at least 1 course of anticancer treatment.

Cellular uptake is measured by reader/visual interpretation, a semiquantitative grading system, and tumor-to-background uptake ratios.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-Hodgkin's lymphoma

    • Indolent or aggressive disease
    • Planning to receive a new regimen or starting a regimen of cancer therapy
  • At least one tumor lesion measurable in two dimensions as ≥ 1.5 cm by CT scan

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy ≥ 3 months
  • No concurrent medical complications that would preclude study compliance
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)
  • At least 3 weeks since prior radiation therapy
  • Concurrent rituximab allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
Number of PBMC and PMNL trafficking prior to vs after therapy
Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gregory Wiseman, MD, Mayo Clinic
  • Principal Investigator: Michael M. Graham, PhD, MD, Holden Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

February 10, 2012

Study Completion (ACTUAL)

February 10, 2012

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000529768
  • UIHC-LS0383
  • MAYO-IRB-1414-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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