Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma

Sponsor

Gilead Sciences (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00003338

Collaborator

(none)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lymphoma	Procedure: immunoscintigraphy Radiation: technetium Tc 99m epratuzumab	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Primary Purpose:

Diagnostic

Official Title:

The Utility of LymphoScan Imaging in the Dectection of Residual Tumor After Chemotherapy and/or Radiotherapy in 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) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
3	Nuclear Physicians Ltd.	Cuyahoga Falls	Ohio	United States	44223
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