Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Omer N. Koc, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|