Neoplasms

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Follicular Lymphoma

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Vaccines

Immunoglobulins

Immunoglobulins, Intravenous

Immunoglobulin Idiotypes

Saponin QA-21V1

Adjuvants, Immunologic

Immunologic Factors

Id-KLH Vaccine

QS-21 (Stimulation-QS-21) Drug

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.

Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype	NCT00001572	B Cell Lymphoma Follicular Lymp... Neoplasm	Id-KLH Vaccine QS-21 (Stimulat...	18 Years -	National Institutes of Health Clinical Center (CC)
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype	NCT00001572	B Cell Lymphoma Follicular Lymp... Neoplasm	Id-KLH Vaccine QS-21 (Stimulat...	18 Years -	National Institutes of Health Clinical Center (CC)
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype	NCT00001572	B Cell Lymphoma Follicular Lymp... Neoplasm	Id-KLH Vaccine QS-21 (Stimulat...	18 Years -	National Institutes of Health Clinical Center (CC)
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype	NCT00001572	B Cell Lymphoma Follicular Lymp... Neoplasm	Id-KLH Vaccine QS-21 (Stimulat...	18 Years -	National Institutes of Health Clinical Center (CC)

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