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

Completed

• Conditions: Lymphoma; Small Intestine Cancer

• Registration Number: NCT00897923
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2012-02-10
• Study Completion: 2012-02-10
• Status Verified: 2016-04
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios
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

Trial Locations

Locations (2)

Holden Comprehensive Cancer Center at University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States