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Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003337
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: December 2001
History of Changes

November 1, 1999
February 6, 2009
March 1997
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Complete list of historical versions of study NCT00003337 on ClinicalTrials.gov Archive Site
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Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma
The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkin's Lymphoma

RATIONALE: Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve the ability to detect and stage non-Hodgkin's lymphoma.

PURPOSE: Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in the detection and staging of patients with non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the radioimmunodetection performance of the imaging agent technetium Tc 99m LL2 monoclonal antibody (LymphoScan) in patients with low, intermediate, and high grade B-cell non-Hodgkin's lymphoma. II. Define the safety of an initial administration of technetium Tc 99m LL2 monoclonal antibody in these patients. III. Demonstrate that diagnostic imaging with this agent can correctly stage patients who have been diagnosed with this disease similarly to noninvasive conventional diagnostic modalities (CDMs), primarily CT scan and bone scan. IV. Demonstrate that imaging with technetium Tc 99m LL2 monoclonal antibody is at least as sensitive for detecting disease in various body sites as any other standard diagnostic imaging method. V. Compare patient management plans based on CDMs alone, technetium Tc 99m LL2 monoclonal antibody alone, and both CDMs and technetium Tc 99m LL2 monoclonal antibody. VI. Describe the human antimouse antibody production in these patients.

OUTLINE: This is an open label, multicenter study. After all other diagnostic studies have been completed, patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody by IV injection or infused over 20-30 minutes as part of their staging 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 technetium Tc 99m LL2 monoclonal antibody. Patients are followed for 3 to 6 months.

PROJECTED ACCRUAL: At least 100 patients will be accrued into this study.
Interventional
Phase 3
Primary Purpose: Diagnostic
Lymphoma
  • Procedure: immunoscintigraphy
  • Radiation: technetium Tc 99m epratuzumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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DISEASE CHARACTERISTICS: Histologically confirmed B-cell non-Hodgkin's lymphoma (low, intermediate, or high grade categories) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: BUN no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN Other: No known allergies to mouse proteins No second primary malignancy within past 5 years other than adequately treated in situ carcinoma of the cervix or uterus, or basal or squamous cell carcinoma of the skin Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior exposure to mouse antibodies other than technetium Tc 99m LL2 monoclonal antibody Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 1 month since any other prior investigational therapy No concurrent participation in another protocol involving medical devices or investigational agents
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Italy,   Sweden,   Switzerland
 
NCT00003337
CDR0000066308, IM-D-LL2-05, NCI-V98-1417
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Immunomedics, Inc.
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Study Chair: William A. Wegener, MD, PhD Immunomedics, Inc.
National Cancer Institute (NCI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP