Anticancer research · 2009
Phase II trial of the association of a methionine-free diet with cystemustine therapy in melanoma and glioma.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Thivat Emilie, Farges Marie-Chantal, Bacin Franck, D'Incan Michel, Mouret-Reynier Marie-Ange, Cellarier Eric, Madelmont Jean-Claude, Vasson Marie-Paule, Chollet Philippe, Durando Xavier
Аннотация
BACKGROUND: In a previous phase I clinical trial of dietary methionine (MET) restriction with cystemustine treatment for melanoma or glioma, we determined the optimal MET-free diet duration to be 1 day. On this basis, a phase II clinical trial was initiated to evaluate safety and efficacy of this combination.
PATIENTS AND METHODS: Twenty-two patients (20 with metastatic melanoma and 2 with recurrent gloma) received a median of 4 cycles of the association of a 1-day MET-free diet with cystemustine (60 mg/m(2)) every two weeks.
RESULTS: This association was well tolerated (toxicity and nutritional status). Toxicity remained mainly hematological and consisted of WHO grade 3-4 thrombocytopenia, leucopenia and neutropenia in 36, 27 and 27% of patients respectively. The median disease-free survival was 1.8 months and the median survival was 4.6 months, with 2 long-duration stabilizations. The plasmatic MET depletion obtained was of 40 + or - 31%.
PATIENTS AND METHODS: Twenty-two patients (20 with metastatic melanoma and 2 with recurrent gloma) received a median of 4 cycles of the association of a 1-day MET-free diet with cystemustine (60 mg/m(2)) every two weeks.
RESULTS: This association was well tolerated (toxicity and nutritional status). Toxicity remained mainly hematological and consisted of WHO grade 3-4 thrombocytopenia, leucopenia and neutropenia in 36, 27 and 27% of patients respectively. The median disease-free survival was 1.8 months and the median survival was 4.6 months, with 2 long-duration stabilizations. The plasmatic MET depletion obtained was of 40 + or - 31%.