Monoclonal Antibody hA20 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

OBJECTIVES:

Primary

- Determine the safety and tolerability of monoclonal antibody hA20 in patients with
refractory CD20-positive B-cell non-Hodgkin's lymphoma.

- Determine the immunogenicity of this drug in these patients.

Secondary

- Determine the pharmacodynamics and pharmacokinetics of this drug in these patients.

- Determine, preliminarily, the efficacy of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20. Up to 10
additional patients are then entered at 1 or more dose levels to determine the optimal dose.

After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12
weeks, and then every 3 months until disease progression.

PROJECTED ACCRUAL: Approximately 19-28 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL)

- Any grade allowed

- CD20-positive disease

- Measurable disease, defined as ≥ 1 bidimensionally measurable lesion > 1.5 cm by CT
scan

- Failed ≥ 1 prior standard chemotherapy regimen OR rituximab therapy for NHL

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-1 OR

- Karnofsky 80-100%

Life expectancy

- At least 6 months

Hematopoietic

- Hemoglobin > 10 g/dL*

- Absolute neutrophil count > 1,500/mm^3*

- Platelet count > 100,000/mm^3* NOTE: *Transfusion independent

Hepatic

- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT < 2.5 times ULN

Renal

- Creatinine < 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 12 months since prior rituximab

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior investigational or conventional chemotherapy and
recovered

Endocrine therapy

- Not specified

Radiotherapy

- Recovered from prior investigational or conventional radiotherapy

- At least 4 weeks since prior radiotherapy to the index lesion

Surgery

- Recovered from prior investigational or conventional surgery