A Phase 1 Trial of Escalating Doses of Karenitecin Plus Cyclophosphamide Administered Intravenously Daily for 5 Consecutive Days in Pediatric Patients With Refractory or Recurrent Solid Tumors (KTN10010)

NCT00586560 Phase 1 COMPLETED

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.

Details

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	COMPLETED
Enrolment	15
Start date	2007-02
Completion	2011-01

Conditions

• Solid Tumors

Interventions

• Kareniticin and cyclophosphamide

Primary outcomes

• To determine the maximum tolerated dose (MTD) levels and recommended Phase 2 dose levels of Karenitecin when administered intravenously for 5 consecutive days with a fixed dose of Cytoxan® — evaluation will extend at least 30 days following the last dose or until toxicities have resolved

Countries

United States