Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma

DISEASE CHARACTERISTICS:

Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes:

Diffuse large B-cell lymphoma
Follicular lymphoma (grades 1-3)
Small lymphocytic lymphoma
Transformed B-cell lymphoma

Relapsed or refractory disease

Disease failed to respond to or progressed after ≥ 2 prior treatment regimens (e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE: *Patients who have received HDT with SCT are considered to have diminished bone marrow reserve

Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the following criteria:

Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor independent)
WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent)
Platelet count ≥ 40,000/mm^3 (25,000/mm^3 if thrombocytopenia is secondary to marrow involvement by lymphoma) but < 150,000/mm^3 (platelet transfusion independent)
At least 1 bidimensionally measurable lymph node or tumor mass ≥ 4 cm

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 16 weeks

Hematopoietic

See Disease Characteristics

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2 times ULN
Albumin ≥ 3.0 g/dL
No history of veno-occlusive disease of the liver
No chronic hepatitis

Renal

Creatinine < 2 times ULN

Cardiovascular

No congestive heart failure
No New York Heart Association class III-IV cardiac disease
No ventricular tachycardia
No fibrillation
No myocardial infarction within the past 12 months

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known HIV positivity
No active GVHD ≥ grade 2 within the past 6 months
No other serious medical illness or active infection that would preclude study participation
No known hypersensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or their excipients)
No other malignancy within the past 5 years except successfully treated carcinoma in situ of the cervix or basal cell carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
At least 6 months since prior allogeneic SCT
No concurrent immunotherapy

Chemotherapy

No concurrent chemotherapy

Endocrine therapy

No concurrent anticancer hormonal therapy
No concurrent corticosteroids for the treatment of NHL

Concurrent corticosteroids allowed for the following conditions:

Tapering doses of corticosteroids for resolving graft-versus-host disease (GVHD)
Low-dose maintenance corticosteroids for the treatment of an autoimmune disorder
Corticosteroids as premedication prior to denileukin diftitox administration or as transient treatment for hypersensitivity reactions

Radiotherapy

More than 4 weeks since prior and no concurrent radiotherapy
No prior radiotherapy to the only site of evaluable disease unless disease progression has occurred at that site

Surgery

Not specified

Other

At least 3 weeks since prior antilymphoma therapy
More than 4 weeks since prior and no other concurrent experimental therapy, including approved drugs tested in an investigational setting