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
  Purpose

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.


Condition Intervention Phase
Lymphoma
Procedure: immunoscintigraphy
Radiation: technetium Tc 99m epratuzumab
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 100
Study Start Date: March 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00003337

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Texas
University of Texas- Houston Medical School
Houston, Texas, United States, 77030
Austria
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
Italy
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Sweden
Lund University Hospital
Lund, Sweden, S-22185
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William A. Wegener, MD, PhD Immunomedics, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003337     History of Changes
Other Study ID Numbers: CDR0000066308, IM-D-LL2-05, NCI-V98-1417
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014