The Genitope Corporation is sponsoring a phase III double-blind, randomized trial of recombinant idiotype immunotherapy in previously untreated patients with follicular lymphoma. The trial will compare the safety and efficacy of a specific immunotherapy—recombinant idiotype conjugated to keyhole limpet hemocyanin (KLH) with granulocyte-macrophage colony-stimulating factor (GM-CSF [Leukine]) support—with nonspecific immunotherapy (KLH with GM-CSF).
Study patients will initially receive eight cycles of the CVP regimen (cyclophosphamide [Cytoxan, Neosar], vincristine, prednisone). If they show at least a 50% reduction in tumor burden (a complete response is not necessary) after completing the initial course of chemotherapy, they will then receive five cycles of immunotherapy over a period of 6 months.
The immunotherapy will consist of either recombinant idiotype or KLH coupled to KLH (idiotype-KLH or KLH-KLH) injected subcutaneously at two sites once a month for 4 months, with a 12-week rest period before the final immunization is administered. In addition, patients will receive subcutaneous GM-CSF on the same day and at the same sites as the initial immunization, followed by once-daily doses for three more days.
The primary objective of the investigation is to demonstrate a statistically significant improvement in time to tumor progression among patients with follicular lymphoma who are in first remission following standard chemotherapy. A secondary objective is to determine the efficacy of the specific immunotherapy (idiotype-KLH with GM-CSF) in converting partial responses to clinical complete responses.
To be eligible, patients must have had no previous therapy, be 18 years of age or older, have stage III/IV disease, and no prior or current central nervous system lymphoma. Patients with a prior malignancy other than curatively treated squamous or basal cell skin cancer or carcinoma in situ of the cervix are ineligible. Pregnant or lactating women are also ineligible, as are patients who have a history of autoimmune disease requiring immunosuppressive therapy.
Investigators plan to biopsy 480 patients, with the expectation that 360 will be eligible to undergo immunization. Approximately 23 sites in Canada and the United States will enroll patients.