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
Recruitment status was Recruiting
Sponsor:
Holden Comprehensive Cancer Center
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
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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 |
| Official Title: | In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Fungal Infections
Intestinal Cancer
Leukemia
Lymphoma
Nuclear Scans
Drug Information available for:
Indium
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2003 |
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 and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897923
Locations
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
Sponsors and Collaborators
Holden Comprehensive Cancer Center
Investigators
| Study Chair: | Gregory Wiseman, MD | Mayo Clinic |
| Principal Investigator: | Michael M. Graham, PhD, MD | Holden Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| 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: | February 16, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Duodenal Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms 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 Ileal Diseases Jejunal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013