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NCT Number: NCT00897923

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.

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Key information

Conditions

Lymphoma Blood Protein Disorders Burkitt Lymphoma Cardiovascular Diseases Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphadenopathy Lymphatic Diseases Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Sezary Syndrome Small Intestine Cancer Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radionuclide imaging

Procedure

indium In 111-labeled autologous peripheral blood mononuclear cells

Radiation

indium In 111-labeled autologous polymorphonuclear leukocytes

Radiation

Primary outcomes

  1. Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors

  2. Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors

  3. Number of PBMC and PMNL trafficking prior to vs after therapy

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
May 12, 2009
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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