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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Lymphoma

Treatments: Biological: apolizumab

Study type: Interventional

Funder types: NIH

Identifiers

NCT00004101

CDR0000067318

UIHC-UICC-LW-02

NCI-T99-0019

Details and patient eligibility

About

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.

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Biological: apolizumab