OBJECTIVES:

• Compare the 9-month objective response rate of patients with recurrent or refractory grade I or II follicular B-cell lymphoma treated with rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine, and sargramostim (GM-CSF) vs historical control patients who received rituximab alone.
• Compare the median duration of response and median time to progression in patients treated with this regimen vs historical controls.
• Determine the immune response (humoral and/or cellular) of patients treated with this regimen.
• Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive rituximab IV once weekly for 4 weeks. Beginning at least 8 weeks later, patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine (Id-KLH) and sargramostim (GM-CSF) subcutaneously once monthly for a total of 6 months in the absence of disease progression or unacceptable toxicity.

Patients who achieve an objective response (complete response or partial response) or stable disease may continue to receive Id-KLH and GM-CSF every other month for a total of 6 doses and then every 3 months in the absence of disease progression.

Patients are followed every 6 months for at least 2 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed grade I or II follicular B-cell lymphoma

• Must meet one of the following criteria for relapsed/refractory disease:

  • Relapsed or refractory after prior chemotherapy

  • Relapsed after prior rituximab

    • Rituximab may have been given as second-line therapy after an initial response to chemotherapy or in combination with chemotherapy as initial therapy

• No more than 2 prior treatment regimens

  • Cyclophosphamide/doxorubicin/prednisone/vincristine (CHOP) and rituximab is considered 1 prior treatment regimen
  • CHOP followed by rituximab at initial relapse is considered 2 prior treatment regimens

• Measurable disease after node biopsy

  • At least 1 bidimensionally measurable lesion
  • If only 1 measurable lesion remains after biopsy, it must be at least 2 cm in each dimension
• Tumor accessible for biopsy or prior recent biopsy material available
• No known history of CNS lymphoma or meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,000/mm^3
• Lymphocyte count less than 5,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST and ALT no greater than 2 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No congestive heart failure

Pulmonary

• No compromised pulmonary function that would preclude study participation, including any of the following:

  • Active asthma
  • Chronic obstructive pulmonary disorder
  • Pneumonitis
  • Bronchiolitis obliterans

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No active uncontrolled bacterial, viral, or fungal infection
• No other concurrent nonmalignant disease that would preclude study participation
• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No prior tumor-specific idiotype immunotherapy using the identical idiotype

Chemotherapy

• See Disease Characteristics
• More than 9 months since prior fludarabine

Endocrine therapy

• No concurrent high-dose steroid therapy

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior investigational drugs
• No concurrent immunosuppressive therapy
• No other concurrent anticancer therapy