Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for 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:
NCT00003338
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: December 2001
  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
Procedure: immunoscintigraphy
Radiation: technetium Tc 99m epratuzumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003338     History of Changes
Other Study ID Numbers: CDR0000066309, IM-D-LL2-06, NCI-V98-1418
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 August 28, 2014