Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: * Evaluate the safety and toxicity of azacitidine plus phenylbutyrate in patients with refractory solid tumors. * Determine the maximum tolerated dose of this treatment regimen where maximal gene reexpression occurs in these patients. * Evaluate the pharmacokinetics of these drugs in these patients. * Determine the minimally effective dose of azacitidine in combination with phenylbutyrate that elicits a biological or clinical response in these patients. OUTLINE: This is a dose escalation study. Patients receive azacitidine subcutaneously for 14-21 days and sodium phenylbutyrate IV continuously for 1-7 days. Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses and durations of treatment with azacitidine and phenylbutyrate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: Approximately 3-50 patients will be accrued for this study within 12-18 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
