Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
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.
Small Intestine Cancer
Procedure: radionuclide imaging
Radiation: indium In 111-labeled autologous peripheral blood mononuclear cells
Radiation: indium In 111-labeled autologous polymorphonuclear leukocytes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy|
- Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors [ Designated as safety issue: No ]
- Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors [ Designated as safety issue: No ]
- Number of PBMC and PMNL trafficking prior to vs after therapy [ Designated as safety issue: No ]
- Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897923
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Gregory Wiseman, MD||Mayo Clinic|
|Principal Investigator:||Michael M. Graham, PhD, MD||Holden Comprehensive Cancer Center|