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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004101

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

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:

Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.
Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.
Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.
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

Study Type:

Interventional

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 :

Nov 1, 1999

Actual Primary Completion Date :

Jun 1, 2005

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

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
3	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21231
4	Biologics Evaluation Section	Bethesda	Maryland	United States	20892-9903
5	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021