Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
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|ClinicalTrials.gov Identifier: NCT00001572|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
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....
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma Follicular Lymphoma Neoplasm||Drug: Id-KLH Vaccine Drug: QS-21 (Stimulation-QS-21) Drug||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Official Title:||Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype|
|Study Start Date :||January 30, 1997|
|Actual Primary Completion Date :||July 31, 1999|
|Actual Study Completion Date :||November 2, 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001572
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|