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
Imunon
OBJECTIVES: * Determine the maximum tolerated dose of doxorubicin HCl liposome released through thermal microwave therapy in patients with adenocarcinoma of the prostate. * Determine the pharmacokinetics and biodistribution profile of this drug in these patients. * Determine the safety profile and dose-limiting toxicity of this drug in these patients. * Determine the clinical response in patients treated with this regimen. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive doxorubicin HCl liposome IV over 30 minutes. Patients then undergo a 60-minute course of prostate thermotherapy. Treatment may repeat every 28-42 days for up to 6 courses, at the discretion of the physician. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 8, 15, 30, and 90 days. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Age
40–any
Sex
MALE
Healthy volunteers
Not accepted
