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

Lymphoma Clinical Trial

Official title:

In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897923
• Other study ID #: CDR0000529768
• Secondary ID: UIHC-LS0383MAYO-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 21, 2017
• Start date: September 2003
• Est. completion date: February 10, 2012

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 10, 2012
• Est. primary completion date: February 10, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Neoplasms
• Lymphoma
• Lymphoma, Non-Hodgkin
• Small Intestine Cancer

Intervention

Procedure:
• radionuclide imaging

Radiation:
• indium In 111-labeled autologous peripheral blood mononuclear cells

• indium In 111-labeled autologous polymorphonuclear leukocytes

Locations

Country	Name	City	State
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
Primary	Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
Primary	Number of PBMC and PMNL trafficking prior to vs after therapy
Primary	Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios