A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma
- Determine progression-free survival in patients with refractory or progressive
follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous
immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab (groups
I and II).
- Determine the immune response rate in patients treated with these regimens (groups I,
II, and III).
- Determine the safety and toxicity of these regimens in these patients (groups I, II,
OUTLINE: This is an open-label, multicenter study for patients previously registered on and
confirmed ineligible for randomization in protocol Genitope-G2000-03.
Patients receive rituximab IV weekly for 4 weeks.
- Group I: The first 30 patients to achieve and maintain a partial response (PR) or
better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously
(SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of
rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations).
- Group II: All subsequent patients who achieve a PR or better receive autologous
immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I
beginning 13 weeks after the last dose of rituximab.
- Group III: Patients who are not eligible for group I or II and, in the investigator's
opinion, are suitable candidates for immunization with autologous immunoglobulin
idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups
I and II, beginning no more than 1 year after the last (fourth) dose of rituximab.
In all groups, treatment continues in the absence of unacceptable toxicity or emergence of
an illness that may interfere with study assessments.
Patients are followed for initial response 8 weeks after completion of immunizations and
then every 12 weeks for an additional year. Thereafter, all immunized patients will be
followed every 6 months until receipt of first subsequent anti-lymphoma therapy.
PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) in groups I and II and median PFS by Kaplan-Meier curves quarterly for 1 year and then twice a year after study completion
Martha Mayo, PharmD
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Cancer Institute at Oregon Health and Science University||Portland, Oregon 97201-3098|
|Stanford Cancer Center at Stanford University Medical Center||Stanford, California 94305|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Rush Cancer Institute at Rush University Medical Center||Chicago, Illinois 60612|