Finding studies
Finding studies
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Lead
OHSU Knight Cancer Institute
With
OBJECTIVES: * Determine the maximum tolerated dose of intra-arterial melphalan when given in combination with BBBD in patients with primary or metastatic central nervous system (CNS) malignancy. * Determine the toxic effects of melphalan given with BBBD in these patients. * Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of melphalan. Patients receive intra-arterial mannitol with BBBD followed by intra-arterial melphalan over 10 minutes on days 1 and 2\*. Treatment repeats every 4 weeks for up to 12 monthly courses in the absence of disease progression or unacceptable toxicity . NOTE: \*Patients with gliomas localized to the posterior circulation (i.e., brain stem gliomas) receive melphalan on day 1 only. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study therapy, patients are followed every 3 months for 1 year; every 6 months for the next 2 years; then annually. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
