Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00004101

Recruitment Status : Completed

First Posted : May 3, 2004

Last Update Posted : February 11, 2013

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Description

Brief Summary:

Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Biological: apolizumab	Phase 1

Detailed Description:

OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
Study Start Date :	November 1999
Actual Primary Completion Date :	June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Lymphosarcoma Follicular Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Burkitt Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm I Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.	Biological: apolizumab

Arm

Intervention/treatment

Experimental: Arm I

Biological: apolizumab

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment
At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present
Measurable or evaluable disease
Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only)
Not eligible for curative conventional therapy

PATIENT CHARACTERISTICS:

Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: At least 3 months
Platelet count at least 75,000/mm3
Bilirubin less than 2.5 mg/dL
SGOT less than 3 times upper limit of normal
Creatinine less than 2.0 mg/dL
No New York Heart Association class III or IV heart disease
No clinically significant pulmonary disease
No active serious infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY:

At least 4 weeks since prior interferon
Concurrent transfusions allowed
At least 4 weeks since prior cytotoxic chemotherapy
No concurrent antineoplastic agents
At least 4 weeks since prior corticosteroids
No concurrent glucocorticoids
At least 4 weeks since prior radiotherapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004101

Locations

Layout table for location information

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Biologics Evaluation Section
Bethesda, Maryland, United States, 20892-9903
United States, New York
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Layout table for investigator information

Study Chair:	Brian Link, MD	Holden Comprehensive Cancer Center

More Information

Publications of Results:

Link BK, Wang H, Byrd JC, et al.: Phase I trial of humanized 1D10 (Hu1D10) monoclonal anitbody class II molecules in patients with relapsed lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A86, 2000.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004101
Other Study ID Numbers:	CDR0000067318 UIHC-UICC-LW-02 NCI-T99-0019
First Posted:	May 3, 2004 Key Record Dates
Last Update Posted:	February 11, 2013
Last Verified:	May 2001

Keywords provided by National Cancer Institute (NCI):


recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma	recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma

Additional relevant MeSH terms:

Layout table for MeSH terms

Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms	Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

To Top