Clinical Trials

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

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated: 02/16/2012

NCT ID:

NCT00897923