ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsored by: Immunomedics, Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003338
  Purpose

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 Intervention Phase
Lymphoma
Drug: technetium Tc 99m epratuzumab
Procedure: immunoscintigraphy
Phase II
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Epratuzumab    Yttrium Y 90 Epratuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic
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

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

Estimated Enrollment:   60
Study Start Date:   March 1997

Detailed Description:

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.

  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) Must have been treated with chemotherapy and/or radiotherapy with evidence of minimal residual disease by conventional diagnostic modalities 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 LymphoScan Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003338

Locations
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
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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066309, IM-D-LL2-06, NCI-V98-1418
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003338
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

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Lymphoblastic lymphoma
Mantle cell lymphoma
Lymphoma, large-cell, immunoblastic
Recurrence
Antibodies, Monoclonal
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Lymphatic Diseases
Antibodies
B-cell lymphomas
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers