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
Daiichi Sankyo
OBJECTIVES: * Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate. * Determine the time to tumor progression in patients treated with this drug. * Determine median survival and 6- and 12-month survival of patients treated with this drug. * Determine the pain response in patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor). Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer). Patients are followed every 3 months for 1 year after withdrawal from study. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
