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
Memorial Sloan Kettering Cancer Center
With
OBJECTIVES: * Compare the number of successful treatment outcomes among patients treated with caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia following cancer therapy, in terms of survival for 7 days after study drug, resolution of fever, treatment of any baseline fungal infection, absence of breakthrough fungal infection during and for 7 days after study drug, and absence of study drug discontinuation due to toxicity or lack of efficacy. * Compare the incidence of nephrotoxicity in patients treated with these regimens. * Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens. * Compare the incidence of treatment discontinuation due to drug-related adverse events, frequency of drug-related events, number of breakthrough fungal infections, and number of successfully treated baseline fungal infections in patients treated with these regimens. * Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens. * Compare the time to resolution of fever in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over 2 hours. * Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV over 2 hours. Treatment repeats daily for up to 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 and 14 days after study drug discontinuation. PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
