IMR Press / FBL / Volume 11 / Issue 1 / DOI: 10.2741/1814

Frontiers in Bioscience-Landmark (FBL) is published by IMR Press from Volume 26 Issue 5 (2021). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on as a courtesy and upon agreement with Frontiers in Bioscience.

Open Access Article
Phase I study of temozolomide and lomustine in the treatment of high grade malignant glioma
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1 Department of Medical Oncology, “S. Maria delle Grazie” Hospital, Pozzuoli; O.C.U. of Radiotherapy, Ascalesi Hospital, Naples; Department of Medical Oncology, National Cancer Institute, Naples, Italy
Academic Editor:Antonio Giordano
Front. Biosci. (Landmark Ed) 2006, 11(1), 502–505;
Published: 1 January 2006
(This article belongs to the Special Issue Gene targets for modulating cell growth)

Systematic reviews and meta-analysis have demonstrated an improved prognosis by chemotherapy of malignant glioma patients. The effects of clinical research therefore have the aim to find more active drugs or new combination therapies. The combination of Temozolomide (TMZ) and nitrosoureas was evaluated preclinically with an evidence of therapeutic synergy. Based on these findings, we have carried out a phase I study with TMZ administered in low, prolonged doses of 75 mg/m2 per day, once a day for 21 days, escalated in cohorts of 3 patients, in combination with a fixed dose of Lomustine (CCNU) 100 mg/m2 orally on day 1. MTD was evident. The treatment was generally well tolerated. We did not observe bleeding or severe infections, as described for several combination chemotherapies with TMZ and other agents. In this study, for the first time in high grade malignant glioma, two orally administrated drugs were associated .TMZ 75 mg/m2 for 28 consecutive days and CCNU 100 mg/m2 on day 1 of every 6 weeks could be recommended as a safe treatment dosage. One of the ten patients evaluated for clinical response showed a partial response, while nine showed stability of disease, with a median duration of from 5 to 6 months.

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