Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

October 31, 2014

Study Completion Date

May 31, 2015

Conditions
Neuroblastoma
Interventions
DRUG

DFMO

"Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID"

DRUG

Etoposide

Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.

Trial Locations (7)

28204

Levine Children's Hospital, Charlotte

32806

Arnold Palmer Hospital for Children- MD Anderson, Orlando

49503

Helen DeVos Children's Hospital, Grand Rapids

64108

Children's Mercy Hospitals and Clinics, Kansas City

92868

Children's Hospital of Orange County, Orange

06106

Connecticut Children's Hospital, Hartford

05401

UVM/FAHC, Burlington

All Listed Sponsors
collaborator

Cancer Prevention Pharmaceuticals, Inc.

INDUSTRY

collaborator

University of Arizona

OTHER

collaborator

University of Hawaii

OTHER

lead

Giselle Sholler

OTHER