@article{1fbfbd08f6014022b8c80c72f0414386,
title = "BiovaxID{\texttrademark}: A personalized therapeutic cancer vaccine for non-Hodgkin's lymphoma",
abstract = "The clonal immunoglobulin molecule, idiotype (ID), expressed on the surface of B-cell malignancies can function as a tumor-specific antigen. BiovaxID{\texttrademark} is a patient-specific therapeutic cancer vaccine composed of the tumor idiotype conjugated to a carrier protein, keyhole limpet hemocyanin (KLH). In a Phase II clinical trial, administration of ID-KLH vaccine together with granulocyte-macrophage colony-stimulating factor to follicular lymphoma patients in complete remission induced tumor-specific cellular and humoral immunity and molecular remissions, and was associated with prolonged disease-free survival. A randomized, double-blind, Phase III clinical trial is ongoing to definitively determine the clinical benefit of BiovaxID plus granulocyte-macrophage colony-stimulating factor vaccination in patients with follicular lymphoma.",
keywords = "BiovaxID{\texttrademark}, Clinical trials, Idiotype, Immunotherapy, Lymphoma, Rituximab, Vaccine",
author = "Lee, {Seung Tae} and Jiang, {Yun Fang} and Park, {Keon Uk} and Woo, {Alison F.} and Neelapu, {Sattva S.}",
note = "Funding Information: Encouraging immunological and clinical outcomes of the Phase II clinical trial that evaluated the ID–KLH plus GM-CSF vaccine in patients with follicular lymphoma led to the initiation of a randomized, double-blind, placebo-controlled, multi-centre Phase III clinical trial to definitively answer the question of clinical benefit induced by ID vaccination. This Phase III trial was initiated by the National Cancer Institute, National Institutes of Health, Bethesda, MD, USA, and is now sponsored by Biovest International, Inc. This trial was designed similar to the Phase II trial [22] in which previously untreated advanced stage follicular lymphoma patients initially underwent an excisional lymph node biopsy and were treated into clinical remission with a PACE chemotherapy regimen. Patients who achieve a CR or complete response unconfirmed (CRu) are randomized in a 2:1 manner either to the specific vaccination arm of ID–KLH plus GM-CSF or the nonspecific vaccination arm of KLH plus GM-CSF (Figure 3). The primary endpoint for this trial is to compare DFS between the two arms [30]. The secondary objectives of this trial are to determine the ability of an ID vaccine to produce a molecular CR in patients in clinical CR by PCR evidence of minimal residual disease after standard chemotherapy; to evaluate the impact of ID vaccine to generate humoral and cellular immunologic responses against autologous tumor; and to compare the overall survival of patients randomized to receive either the autologous tumor-derived ID vaccination (ID–KLH plus GM-CSF) or nonspecific vaccination (KLH plus GM-CSF).",
year = "2007",
month = jan,
doi = "10.1517/14712598.7.1.113",
language = "English (US)",
volume = "7",
pages = "113--122",
journal = "Expert Opinion on Biological Therapy",
issn = "1471-2598",
publisher = "Informa Healthcare",
number = "1",
}