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
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.
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.
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