Primary Outcome Measures:
- To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients [ Time Frame: until date of relapse ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ] [ Designated as safety issue: No ]
- To determine the impact of molecular disease free survival [ Time Frame: until relapse ] [ Designated as safety issue: No ]
- To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ] [ Designated as safety issue: No ]
- To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ] [ Designated as safety issue: No ]
- To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
Purpose
