Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma

Sponsor

Gilead Sciences (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00003337

Collaborator

(none)

100

Enrollment

Locations

12.5

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Procedure: immunoscintigraphy Radiation: technetium Tc 99m epratuzumab	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Primary Purpose:

Diagnostic

Official Title:

The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkin's Lymphoma

Study Start Date :

Mar 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Morton Plant Mease Health Care	Clearwater	Florida	United States	33756
3	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
4	University of Texas- Houston Medical School	Houston	Texas	United States	77030
5	Innsbruck Universitaetsklinik	Innsbruck		Austria	A-6020
6	Istituto Europeo Di Oncologia	Milano		Italy	20141
7	Lund University Hospital	Lund		Sweden	S-22185
8	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011