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Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00897923
First received: May 9, 2009
Last updated: March 21, 2017
Last verified: April 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| 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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
B-cell Lymphoma
Diffuse Large B-Cell Lymphoma
Lymphosarcoma
Primary Central Nervous System Lymphoma
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Mantle Cell Lymphoma
Waldenstrom Macroglobulinemia
Leukemia, T-cell, Chronic
Extranodal Nasal NK/T Cell Lymphoma
Follicular Lymphoma
Cutaneous T-cell Lymphoma
Adult T-cell Leukemia/lymphoma
Burkitt Lymphoma
Marginal Zone Lymphoma
Lymphoma, Large-cell
Anaplastic Large Cell Lymphoma
Small Intestine Cancer
Lymphoblastic Lymphoma
Angioimmunoblastic T-cell Lymphoma
Angioimmunoblastic Lymphadenopathy With Dysproteinemia
Mycosis Fungoides
Sezary Syndrome
Lymphomatoid Granulomatosis
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
- Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
- Number of PBMC and PMNL trafficking prior to vs after therapy
- Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios
| Enrollment: | 17 |
| Study Start Date: | September 2003 |
| Study Completion Date: | February 10, 2012 |
| Primary Completion Date: | February 10, 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
community sample
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897923
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897923
Locations
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
| Study Chair: | Gregory Wiseman, MD | Mayo Clinic |
| Principal Investigator: | Michael M. Graham, PhD, MD | Holden Comprehensive Cancer Center |
More Information
| Responsible Party: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00897923 History of Changes |
| Other Study ID Numbers: |
CDR0000529768 UIHC-LS0383 MAYO-IRB-1414-03 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 21, 2017 |
Keywords provided by Mayo Clinic:
|
AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue intraocular lymphoma nodal marginal zone B-cell lymphoma primary central nervous system non-Hodgkin lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma |
recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma small intestine lymphoma splenic marginal zone lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on August 23, 2017