A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage II-IV low-grade, mantle cell, or
follicular B-cell lymphoma Stage I disease is eligible only if radiotherapy is not
considered feasible due to location of disease or previous radiation treatments No chronic
lymphocytic lymphoma No small lymphocytic lymphoma with lymphocyte count greater than
5,000/mm3 Must be either first-line therapy or no more than 4 relapses after standard
therapies, including chemotherapy, radiotherapy, autologous bone marrow transplantation,
and/or immunotherapy Eligible if refractory to first treatment with a standard therapy
Patients refractory to autologous bone marrow transplantation (ABMT) or relapsed after
ABMT are eligible Patients with low-grade or follicular lymphoma must have failed at least
one chemotherapy regimen Patients with mantle cell lymphoma are eligible even if no prior
treatment Bidimensionally measurable disease Demonstrable monoclonal CD20-positive B-cell
population in lymph nodes or bone marrow No prior diagnosis of intermediate or high-grade
non-Hodgkin's lymphoma No CNS, pericardial, pleural, or peritoneal involvement by lymphoma
No AIDS-related lymphoma No pleural effusion No ascites 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 to 75 Performance status: ECOG 0-2 Life expectancy: At
least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) SGOT no
greater than 2 times ULN Renal: Creatinine clearance at least 65 mL/min Cardiovascular:
See Disease Characteristics No pericardial effusion No New York Heart Association class
III or IV heart disease No myocardial infarction within the past 6 months Other: No
active, uncontrolled bacterial, viral, or fungal infection No active opportunistic
infection No active inflammatory arthritis (excluding degenerative joint disease) No known
hypersensitivity to interleukin-2 No history of an autoimmune disorder No history of
seizure disorder No other primary malignancy in the past 5 years except squamous cell or
basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior
radioimmunotherapy At least 6 months since prior autologous bone marrow transplantation
and recovered At least 4 weeks since prior colony-stimulating factors or epoetin alfa At
least 3 weeks since prior immunotherapy and recovered No concurrent hematopoietic growth
factors Chemotherapy: See Disease Characteristics At least 3 weeks since prior
chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: At
least 3 weeks since prior corticosteroids No corticosteroids during or for 8 weeks after
study Radiotherapy: See Disease Characteristics See Biologic therapy At least 3 weeks
since prior radiotherapy and recovered Surgery: Not a recipient of an allogeneic organ
transplantation, unless organ is no longer functional At least 4 weeks since any prior
major surgery (except diagnostic surgery) and recovered