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
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.
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.
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