Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
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 goals of
vaccine development in the current study are to develop vaccines: 1) with improved potency
and 2) which are more effective at inducing cell-mediated immune responses. The selection
of GM-CSF as the immunological "adjuvant" is a direct extension of our laboratory studies in
small animal models demonstrating that GM-CSF can enhance the potency of the prototype
Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response.
The objectives of this study are: 1) to evaluate cellular and humoral immune responses
against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the
Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination
or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2
oncogene).
The goal of this study is to treat previously untreated patients with follicular lymphomas
to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six
months after completion of chemotherapy, in an effort to reduce the relapse rate (by
eradicating microscopic disease resistant to chemotherapy), patients will receive an
autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is
administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine
on the day of vaccination and for the three consecutive days following vaccination as close
to the initial vaccination site as possible at one of two doses.
Interventional
Primary Purpose: Treatment
United States: Federal Government
960133
NCT00001512
September 1996
March 2010
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |