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
University of Wisconsin, Madison
With
OBJECTIVES: * Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies. * Determine the dose-limiting toxicity of this regimen in these patients. * Determine the safety and tolerability of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Evaluate the tumor response in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups. Group A: * Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8. * Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes. * Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days. Group B: * Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8. * Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. * Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and motexafin gadolinium as in group A. Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m\^2. Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 and 2 months. PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
