Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Institutes of Health Clinical Center (CC)
With
OBJECTIVES: * Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs. * Determine the toxicity of this regimen in these patients. * Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients. * Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of doxorubicin 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. Patients are followed at 3 weeks and 3 months. PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
