CIGB-128, as compassionate intracranial treatment in patients with non-operable or progressive high grade gliomas
Journal Title: Journal of Cancer Research & Therapy - Year 2015, Vol 3, Issue 11
Abstract
Background: High grade glioma (HGG) is the most aggressive and lethal primary brain tumor. The treatment of patients with HGG still remains palliative with improvement in the quality of life and encompasses surgery, radiotherapy, and chemotherapy. The use of interferons (IFNs) in the treatment of HGG has been showed useful for these patients. Patients and methods: We report the use, outside of clinical trials, of recombinant IFNs-α and γ(CIGB-128) in 10 patients with glioma grade III-IV (1 anaplastic astrocytoma and 9 GBM). The aim of the study was to offer a treatment option to patients with malignant gliomas, primary (non-surgical) or progressive (Karnofsky performance status (KPS) >20), without other possible therapeutic options, and non-eligible for clinical trials. Patients received intralesional CIGB-128, 3 times per week, during one month, in doses from 3.5 MIU scalable up to 14.0 MIU. Safety was evaluated by the occurrence of adverse events. Others measurements were tumor responses measured by RECIST, KPS, muscular power (ASIA neurological assessment scale) and overall survival. Depending of treatment tolerability, clinical improvement and medical criteria, patients were maintained under treatment for 3 more months. Results: 70% of treated patients had KS<50. Seven patients had objective response (3 CR, 4 PR), one lesion progressed and 2 were not evaluable. The treatment prolonged the survival of patients to a mean of 34±14 months since diagnosis. The quality of life improved as measured by the increase in the KPS (66% of patients scaled the category) and improvement in muscular power in 50% of patients. CIGB-128 had an acceptable safety profile with fever as the most frequent adverse event, observed in 54.7%, followed by extrapyramidal symptoms and hypopotassemia in 14.2% of treated patients. All detected adverse events were reversible. There was no evidence of cumulative hematologic toxicity. Conclusions: CIGB-128 demonstrated signs of clinical improvement, with an acceptable safety profile and measurable improvement in quality of life in patients with non-operable or progressive highgradeglioma. The use of this drug should be explored further in clinical trials with a larger number of patients to confirm these encouraging results.
Authors and Affiliations
Garcia-Vega Y, Salva-Camaño S, García-Iglesias E, Cubero-Rego D, González-Gonzalez J, Bello-Rivero I
Keywords
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- EP ID EP547257
- DOI 10.14312/2052-4994.2015-20
- Views 59
- Downloads 0
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