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Home > "M" Clinical Trials Conditions > Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma  Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): Immunomedics, Inc. ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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.] --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamWegener, Study Chair, Immunomedics, Inc.
Lund University Hospital
Lund, , S-22185
Sweden
Nuclear Physicians Ltd.
Cuyahoga Falls, Ohio, 44223
United States
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Istituto Europeo Di Oncologia
Milano, , 20141
Italy
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Texas- Houston Medical School
Houston, Texas, 77030
United States
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Additional Information:
Study ID Numbers: CDR0000066309; IM-D-LL2-06,NCI-V98-1418
Study Start Date: March 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003338
Other Lymphoma Studies:
1. ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma
2. Stem Cell Transplantation in Treating Patients with Hematologic Cancer
3. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
4. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
5. Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
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Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
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