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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897923
First received: May 9, 2009
Last updated: February 16, 2012
Last verified: March 2007

May 9, 2009
February 16, 2012
September 2003
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  • 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 ]
Same as current
Complete list of historical versions of study NCT00897923 on ClinicalTrials.gov Archive Site
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Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy

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.

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.

Observational
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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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
Both
18 Years and older
No
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United States
 
NCT00897923
CDR0000529768, UIHC-LS0383, MAYO-IRB-1414-03
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Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Gregory Wiseman, MD Mayo Clinic
Principal Investigator: Michael M. Graham, PhD, MD Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP