Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed low-grade lymphoma including any of the
following: REAL classification Follicular lymphoma (grade I or II) Lymphoplasmacytoid
lymphoma Small lymphocytic lymphoma Marginal B-cell lymphoma MALT lymphoma International
Working Formulation Follicular small cleaved cell lymphoma Follicular mixed small and
large cell lymphoma Small lymphocytic lymphoma No intermediate or high-grade non-Hodgkin's
lymphoma (NHL) histology No evidence of histologic transformation If previously untreated,
large tumor burden including any of the following: Nodal or extranodal mass greater than 7
cm in diameter Involvement of at least 3 nodal sites (each greater than 3 cm in diameter)
Systemic symptoms Splenomegaly Ureteral compression Intraabdominal stage II, stage III, or
stage IV disease Measurable disease No prior systemic therapy OR No more than 1 prior
therapy ( e.g., chemotherapy, immunotherapy, chemotherapy with immunotherapy, or
chemotherapy with regional radiotherapy) A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm3 Absolute neutrophil
count greater than 1,500/mm3 Platelet count greater than 75,000/mm3 Hemoglobin greater
than 10 g/dL Absolute lymphocyte count no greater than 5,000/mm3 Hepatic: Bilirubin less
than 1.5 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline
phosphatase less than 2.5 times ULN No active hepatitis Renal: Creatinine less than 1.5
times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No severe
cardiovascular disease No myocardial infarction within the past 6 months No unstable
angina No class III or IV congestive heart failure No ventricular tachyarrhythmias Other:
No active uncontrolled infections or infections requiring systemic antibiotics HIV
negative No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix No history of neuropsychiatric disorder requiring
hospitalization Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 12 weeks
since prior immunotherapy (e.g., rituximab) No prior cytokines (except filgrastim (G-CSF)
or epoetin alfa) Chemotherapy: See Disease Characteristics Endocrine therapy: No
concurrent systemic corticosteroids Radiotherapy: See Disease Characteristics Surgery: Not
specified