Phase II trial of the association of a methionine-free diet with cystemustine therapy in melanoma and glioma.
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.


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%.
Thivat
Emilie
E
Centre Jean Perrin, 58 rue Montalembert, BP 392, 63011 Clermont-Ferrand cedex 1, France. Recherche.CLINIQUE@cjp.fr
Farges
Marie-Chantal
MC
Bacin
Franck
F
D'Incan
Michel
M
Mouret-Reynier
Marie-Ange
MA
Cellarier
Eric
E
Madelmont
Jean-Claude
JC
Vasson
Marie-Paule
MP
Chollet
Philippe
P
Durando
Xavier
X
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000378:metabolism / Q000556:secondary / Q000628:therapy*; D002830:Choroid Neoplasms / Q000378:metabolism / Q000556:secondary / Q000628:therapy*; D003131:Combined Modality Therapy; D004032:Diet; D005260:Female; D005910:Glioma / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008545:Melanoma / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D008715:Methionine / Q000008:administration & dosage / Q000172:deficiency*; D008875:Middle Aged; D009367:Neoplasm Staging; D009607:Nitrosourea Compounds / Q000627:therapeutic use*; D009752:Nutritional Status; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; C051263:N'-(2-chloroethyl)-N-(2-(methylsulfonyl)ethyl)-N'-nitrosourea; D008715:Methionine