Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

October 8, 2015

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Neuroblastoma
Interventions
DRUG

Sorafenib

Sorafenib -100-200mg/m2/dose (dose escalation), Orally BID continuously Days 1 thru 28 Cyclophosphamide - 250 mg/m2/day IV x 5 days - day 1 thru day 5 Topotecan - 0.75 mg/m2/day IV x 5 days - day 1 thru day 5

DRUG

Cyclophosphamide

250mg/m2/day IV x5 days (Day 1 through Day 5 of each course)

DRUG

Topotecan

0.75mg/m2.day IV x5 days (Day 1 through Day 5 of each course)

Trial Locations (12)

27599

University of North Carolina, Chapel Hill

30322

Children's Healthcare of Atlanta, Atlanta

48109

C.S Mott Children's Hospital, Ann Arbor

60637

University of Chicago, Comer Children's Hospital, Chicago

76104

Cook Children's Healthcare System, Fort Worth

80045

Children Hospital of Colorado, Aurora

94143

UCSF Comprehensive Cancer Center, San Francisco

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

90027-0700

Children's Hospital Los Angeles, Los Angeles

02115

Childrens Hospital Boston, Dana-Farber Cancer Institute., Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

M5G 1X8

Hospital for Sick Children, Toronto

Sponsors
All Listed Sponsors
collaborator

University of California, San Francisco

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

Lucile Packard Children's Hospital

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

University of Michigan

OTHER

collaborator

Seattle Children's Hospital

OTHER

collaborator

Dana-Farber Cancer Institute

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Children's Healthcare of Atlanta

OTHER

collaborator

University of Chicago

OTHER

collaborator

Cook Children's Health Care System

OTHER

collaborator

Children's Hospital Colorado

OTHER

lead

New Approaches to Neuroblastoma Therapy Consortium

OTHER