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

NCT ID: NCT00897923

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2012-02-10

Brief Summary

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.

Detailed Description

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.

Conditions

Lymphoma; Small Intestine Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

radionuclide imaging

Intervention Type: PROCEDURE

indium In 111-labeled autologous peripheral blood mononuclear cells

Intervention Type: RADIATION

indium In 111-labeled autologous polymorphonuclear leukocytes

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Wiseman, MD

Role: STUDY_CHAIR

Mayo Clinic

Michael M. Graham, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Holden Comprehensive Cancer Center

Locations

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

UIHC-LS0383

Identifier Type: -

Identifier Source: secondary_id

MAYO-IRB-1414-03

Identifier Type: -

Identifier Source: secondary_id

CDR0000529768

Identifier Type: -

Identifier Source: org_study_id