A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas

Date de début de l'étude : 1 juillet 1999

DISEASE CHARACTERISTICS: Histologically proven malignant glioma of one of the following types: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Progressive or recurrent disease after radiotherapy with or without chemotherapy Measurable disease by serial MR or CT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 2 months Hematopoietic: Absolute neutrophil count at least 1500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT/SGOT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.7 mg/dL Other: No serious concurrent infection No other illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) during the first course Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively No prior procarbazine Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy Surgery: Prior surgery allowed Other: Recovered from toxicity of prior therapy At least 10 days since prior anticonvulsants for patients in Arm II No concurrent investigational agents No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor) Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)