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

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Solid Tumors
Interventions
DRUG

Kareniticin and cyclophosphamide

"An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle).~Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity."

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Pediatric Brain Tumor Consortium

NETWORK

lead

Baylor College of Medicine

OTHER

NCT00586560 - Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010) | Biotech Hunter | Biotech Hunter