Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)

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.

Timeline

Start

2007-02

Primary completion

2011-01

Completion

2011-01

Drugs

Indications