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

NCT ID: NCT00004101

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

apolizumab

Intervention Type: BIOLOGICAL

Interventions

apolizumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Link, MD

Role: STUDY_CHAIR

Holden Comprehensive Cancer Center

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Biologics Evaluation Section

Bethesda, Maryland, United States

New York Presbyterian Hospital - Cornell Campus

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

UIHC-UICC-LW-02

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0019

Identifier Type: -

Identifier Source: secondary_id

CDR0000067318

Identifier Type: -

Identifier Source: org_study_id