- 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.
- 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
- 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
Last updated: 02/16/2012
NCT ID: NCT00897923