Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria:

• Histologically confirmed relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL)

  • WHO grade 1 or 2
  • Failure to achieve a complete or partial remission after prior treatment regimen
  • Relapse or disease progression within 30 days after prior treatment regimen
• No histologic transformation to aggressive NHL or areas of diffuse NHL
• At least 1 measurable lesion by CT scan, MRI, or chest x-ray
• Tissue in the form of tissue blocks available
• No brain metastasis or primary brain tumors
• Performance status - ECOG 0-1
• More than 3 months
• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin greater than 8.5 g/dL
• Bilirubin no greater than 1.5 mg/dL
• SGOT/SGPT no greater than 2.5 times upper limit of normal
• PT (or INR)/PTT normal or not clinically significant
• No preexisting liver disease
• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance greater than 60 mL/min
• No uncompensated coronary artery disease
• No myocardial infarction or severe/unstable angina within the past 6 months
• No active infection
• No prior gastrointestinal disorder that would interfere with thalidomide absorption
• No preexisting autoimmune disease
• No medical, psychological, or social problem that would preclude study participation
• No uncontrolled or untreated depression
• No emotional disorder or substance abuse
• No prior seizures or potential risk factors for development of seizures
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test at baseline, weekly for 4 weeks, and then every 2-4 weeks thereafter while on study
• Fertile female patients must use 1 highly active method and 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study
• Fertile male patients must use effective barrier contraception during and for 4 weeks after study participation
• No more than 1 prior course of unconjugated monoclonal antibody therapy
• No prior conjugated monoclonal antibody (radiolabeled or immunotoxin) therapy
• No prior interferon alfa
• No concurrent hematopoietic growth factors or other cytokines
• No concurrent monoclonal antibodies
• No more than 2 prior chemotherapy regimens (single agent or combination)
• At least 28 days since prior chemotherapy
• No concurrent chemotherapy
• At least 28 days since prior corticosteroid therapy
• Prior or concurrent megestrol allowed
• No concurrent corticosteroids
• No concurrent hormonal therapy
• Prior palliative radiotherapy to nontarget lesions allowed
• No prior radiotherapy to all sites of measurable disease
• No prior extensive radiotherapy to more than 20% of bone marrow
• No concurrent palliative radiotherapy
• At least 14 days since prior major surgery
• No prior major upper gastrointestinal surgery
• No other concurrent cytotoxic agents
• No other concurrent investigational therapy
• No other concurrent anticancer therapy