Overview

This trial is active, not recruiting.

Conditions lymphoma, small intestine cancer
Treatments radionuclide imaging, indium in 111-labeled autologous peripheral blood mononuclear cells, indium in 111-labeled autologous polymorphonuclear leukocytes
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date September 2003
End date December 2016
Trial size 100 participants
Trial identifier NCT00897923, CDR0000529768, MAYO-IRB-1414-03, UIHC-LS0383

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy
Principal investigator Michael M. Graham, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.