Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00003338|
Recruitment Status : Unknown
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 12, 2004
Last Update Posted : February 9, 2009
RATIONALE: Diagnostic imaging procedures, such as radiolabeled monoclonal antibodies, may improve the ability to detect the residual disease in patients who have been treated for non-Hodgkin's lymphoma.
PURPOSE: Phase II/III trial to study the effectiveness of monoclonal antibodies in detecting residual disease in patients who have been treated for non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Procedure: immunoscintigraphy Radiation: technetium Tc 99m epratuzumab||Phase 2 Phase 3|
OBJECTIVES: I. Evaluate the safety of multiple (2-3) administrations of technetium Tc 99m LL2 monoclonal antibody (LymphoScan) in patients with B-cell non-Hodgkin's lymphoma after chemotherapy and/or radiotherapy. II. Describe human antimouse antibody production in these patients. III. Demonstrate that addition of a single LymphoScan study to conventional diagnostic modalities (CDMs) can differentiate between tumor and residual scarring. IV. Determine the diagnostic operating characteristics of LymphoScan to detect residual tumor in patients with radiologically detectable masses. V. Compare patient management plans based on CDMs alone and both CDMs and LymphoScan.
OUTLINE: This is an open label, multicenter study. Patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody (LymphoScan) by IV injection or infused over 20-30 minutes after completion of therapy as part of the response evaluation procedures. Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection, and single photon emission computerized tomography (SPECT) imaging is performed between 4-8 hours following antibody injection. Patients may receive a repeat injection of LymphoScan. Patients are followed for 3 to 6 months.
PROJECTED ACCRUAL: There will be 60 patients accrued into this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||The Utility of LymphoScan Imaging in the Dectection of Residual Tumor After Chemotherapy and/or Radiotherapy in Patients With Non-Hodgkin's Lymphoma|
|Study Start Date :||March 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003338
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Ohio|
|Nuclear Physicians Ltd.|
|Cuyahoga Falls, Ohio, United States, 44223|
|United States, Texas|
|University of Texas- Houston Medical School|
|Houston, Texas, United States, 77030|
|Innsbruck, Austria, A-6020|
|Istituto Europeo Di Oncologia|
|Milano, Italy, 20141|
|Lund University Hospital|
|Lund, Sweden, S-22185|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||William A. Wegener, MD, PhD||Immunomedics, Inc.|