Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00004101

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 5 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00004101

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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