Phase I study of temozolomide and lomustine in the treatment of high grade malignant glioma.
|
| Abstract |
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.
|
|---|---|
| Authors | Salvatore Tafuto, Paolo Muto, Anna Tortoriello, Agata Pisano, Pasquale Comella, Roberta Formato, Stefano Quattrin, Rosario Vincenzo Iaffaioli |
| Journal | Frontiers in bioscience : a journal and virtual library (Front Biosci) Vol. 11 Pg. 502-5 (Jan 01 2006) ISSN: 1093-9946 [Print] United States |
| PMID | 16146748 (Publication Type: Clinical Trial, Phase I, Journal Article) |
| Chemical References |
|
| Topics |
|
Join CureHunter, for free Research Interface BASIC access!
Realize the full power of the drug-disease research graph!