Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML
Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal
annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment
will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the
MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels
of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary
objectives of this study are 1) to evaluate the safety and identify the maximum tolerated
dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130
mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in
children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or
acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal
annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary
objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.