Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2
- Assess the safety of immunotherapy with autologous tumor cell vaccine and interleukin-2
in patients with stage III, IV, or recurrent follicular lymphoma.
- Determine the clinical response of patients treated with this regimen.
- Assess the immune response of patients treated with this vaccine.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (no
prior biologic therapy or chemotherapy for lymphoma vs prior prednisone, doxorubicin,
cyclophosphamide, and etoposide (PACE) chemotherapy). Patients without prior therapy are
further stratified according to accessibility of lymph nodes (easily accessible (stratum Ia)
vs not easily accessible (stratum Ib)).
All patients undergo lymph node biopsy to obtain tissue for vaccine manufacture. Treatment
begins approximately 1 month after biopsy.
- Stratum Ia: Patients receive autologous tumor cell vaccine and interleukin-2 (IL-2)
intranodally and subcutaneously (SC) on day 1.
- Stratum Ib and stratum II: Patients receive autologous tumor cell vaccine and IL-2 SC
on day 1.
Treatment in each stratum continues every 4 weeks for a maximum of 5 courses in the absence
of disease progression or unacceptable toxicity.
Patients are followed at 1 and 4 months, every 3 months for 1 year, and every 6 months
thereafter until relapse or progression of disease.
PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study
within 1.5-2 years.
Primary Purpose: Treatment
Sattva S. Neelapu, MD
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|