The Molecular Biology and Immunology of Glioblastoma Multiforme (Gbm) with the Presentation of an Immunotherapy Protocol for a Clinical Trial

Sinkovics, J. G. and Horvath, J. C. (2006) The Molecular Biology and Immunology of Glioblastoma Multiforme (Gbm) with the Presentation of an Immunotherapy Protocol for a Clinical Trial. Acta Microbiologica et Immunologica Hungarica, 53 (4). pp. 367-429. ISSN 1217-8950

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Abstract

After a short explanatory Introduction, an immunotherapy protocol is presented for glioblastoma multiforme (GBM). GBM is considered to be an incurable tumor; tumor-free survival over 2 to 3 years is so rare that when it happens the original diagnosis is questioned. It is known that the type of the genetic mutation that a given GBM tumor harbors strongly influences the length of survival. However, most patients with GBM are receiving treatment without the preparation of a microarray gene map of their tumors. It is possible that the reason for a rare and exceptional long survival was not the treatment that the patient received, but the type of gene mutations that the tumor was exposed to. It is recognized that any therapeutic approach should ideally be evaluated against the background of all prognostic factors of each individual case, prominent among them the microarray gene map of the tumor. In practice, this is not easily achieved, while the patient is in need of, and is expecting, prompt therapy. Insurance companies do not reimburse the patient, or the clinical investigators, or their institutions for investigational diagnostic tests, or such treatment modalities. A temporary compromise is possible. The emergence of empirically administered treatment modalities with extraordinary efficacy has occasionally been recorded in the history of medical oncology. In some of these rare clinical trials, the control groups were discontinued (to the dismay of the statisticians), and the control patients were enrolled in the treatment groups so to escape doom and share the benefit of the unfolding high remission inductions experienced in the treatment group. Chemo-radiotherapy of Hodgkin's disease and cisplatin therapy of certain testicular carcinomas provided the first éclat examples. More recently, the rapidly approved and marketed imitanib mesylate for Ph-chromosome-positive chronic myelogenous leukemia and the anti-HER2/neu monoclonal antibody trastuzumab, and the not yet marketed double tyrosine kinase (ErbB1/2) inhibitor lapatinib (Tykerb, GlaxoSmithKline) for a subgroup of breast carcinoma patients excelled. Thus, a clinical trial for GBM, but without precise pre-identification of all its prognostic factors, however with a great deal of evidence-based empirical expectations of benefits, for patients with rapid advancement toward a fatal outcome, implying an element of urgency, appears to be justified.

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