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	Treatment or Intervention	Phase
Lymphoma	Drug: technetium Tc 99m monoclonal antibody LL2	Phase II Phase III

Further Study 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.

Ages Eligible for Study:  16 Years and above

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

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Ohio
      Nuclear Physicians Ltd., Cuyahoga Falls,  Ohio,  44223,  United States
Texas
      University of Texas- Houston Medical School, Houston,  Texas,  77030,  United States
Austria
      Innsbruck Universitaetsklinik, Innsbruck,  A-6020,  Austria
Italy
      Istituto Europeo Di Oncologia, Milano,  20141,  Italy
Sweden
      Lund University Hospital, Lund,  S-22185,  Sweden
Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland

Study chairs or principal investigators

William A. Wegener,  Study Chair,  Immunomedics, Inc.   

Study ID Numbers:  CDR0000066309; IM-D-LL2-06; NCI-V98-1418
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003338
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08