A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors
Upon obtaining informed consent, patients will begin two courses of oral cyclophosphamide
and topotecan x 14 days. During the first of two courses, patients will perform the
14C-Erythromycin Breath Test and have topotecan pharmacokinetics performed on day 1 and 14.
The subjects will also have various medical tests and procedures performed that are part of
regular cancer care which include: Medical history and physical examination to be done
weekly, blood tests to be done weekly, heart and kidney function tests, various scans to be
done after two courses of treatment, and a pregnancy test for females of childbearing age to
be done prior to starting treatment.
Patients may continue to receive additional courses of oral cyclophosphamide and topotecan
provided that they do not experience tumor progression or intolerable side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Every 2 cycles
Daniel C Bowers, MD
UT Southwestern Medical Center of Dallas
United States: Institutional Review Board
|Children's Medical Center Dallas||Dallas, Texas 75235|