Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
OBJECTIVES:
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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.
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Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these patients.
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Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking of PBMCs vs PMNLs in these patients.
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Gather important data regarding the inter- and intra-patient variability of effector cell trafficking into these tumors.
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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.
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Group I: Patients receive autologous indium In 111 (^111In)-labeled peripheral blood mononuclear cells on day 0.
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Group II: Patients receive autologous ^111In-labeled polymorphonuclear leukocytes on day
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 Design
Outcome Measures
Primary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed non-Hodgkin's lymphoma
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Indolent or aggressive disease
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Planning to receive a new regimen or starting a regimen of cancer therapy
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At least one tumor lesion measurable in two dimensions as ≥ 1.5 cm by CT scan
PATIENT CHARACTERISTICS:
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ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
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Life expectancy ≥ 3 months
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No concurrent medical complications that would preclude study compliance
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Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
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At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)
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At least 3 weeks since prior radiation therapy
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Concurrent rituximab allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
| 2 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Study Chair: Gregory Wiseman, MD, Mayo Clinic
- Principal Investigator: Michael M. Graham, PhD, MD, Holden Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000529768
- UIHC-LS0383
- MAYO-IRB-1414-03