Follicular Lymphoma Clinical Trial
Official title:
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Patients undergo chemotherapy until remission is obtained, or disease has been stable for two
cycles of chemotherapy, or progressive disease develops.
Three to six months after completion of chemotherapy, patients who have achieved complete
clinical remission or minimal disease status receive a series of 5 injections (given 1-2
months apart) of a vaccine consisting of 0.5 mg autologous tumor-derived immunoglobulin (Id)
conjugated to KLH. The vaccine is administered with subcutaneous QS-21 as an immunological
adjuvant....
The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal
marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id
protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a
carrier protein (KLH) and administration with an emulsion-based adjuvant.
The objectives of this study are: 1) to evaluate feasibility and toxicity of new vaccine
formulations, and 2) to evaluate cellular and humoral immune responses against the unique
idiotype of the patient's lymphoma.
The goal of this study is to treat patients with follicular lymphomas to complete remission
or minimal residual disease with chemotherapy. Six to twelve months after completion of
chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease
resistant to chemotherapy), patients will receive one of two new formulations of an
autologous Id vaccine.
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