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 immunotherapyrecombinant
idiotype conjugated to keyhole limpet hemocyanin (KLH) with
granulocyte-macrophage colony-stimulating factor (GM-CSF [Leukine]) supportwith
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
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.