|
Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma Clinical research trials and Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma. Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma  Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma
Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma
For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): Immunomedics, Inc. ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
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) [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 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 --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.
Morton Plant Mease Health Care
Clearwater, Florida, 33756
United States
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Istituto Europeo Di Oncologia
Milano, , 20141
Italy
Lund University Hospital
Lund, , S-22185
Sweden
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
University of Texas- Houston Medical School
Houston, Texas, 77030
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Additional Information:
Study ID Numbers: CDR0000066308; IM-D-LL2-05,NCI-V98-1417
Study Start Date: March 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003337
Other Lymphoma Studies:
1. Phase II Liposomal Vincristine for Pediatric and Adolescent Patients with Relapsed Malignancies
2. Phase I Study of Intrathecal Mafosfamide
3. Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
4. Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
5. Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
Related Studies:
Other Lymphoma Clinical Trials
Other Clinical Trials
Other Lausanne Clinical Trials
Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma
|
|
|
|
|
|
|
|
