Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients
with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata,
depending upon the presence bone marrow metastases or previous treatment with intensive
myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily
for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to
20 cycles, as long as there is continued evidence of clinical benefit and an absence of
unacceptable toxicity.