Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Neuroblastoma
Interventions
DRUG

TPI 287

Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.

DRUG

Temozolomide

Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle

DRUG

Irinotecan

Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.

Trial Locations (8)

28204

Levine Children's Hospital, Charlotte

32806

Arnold Palmer Hospital for Children- MD Anderson, Orlando

49503

Helen DeVos Children's Hospital, Grand Rapids

63104

Cardinal Glennon Children's Medical Center, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

92123

Rady Children's Hospital, San Diego

Unknown

Phoenix Children's Hospital, Phoenix

06106

Connecticut Children's Hospital, Hartford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cortice Biosciences, Inc.

INDUSTRY

lead

Giselle Sholler

OTHER

NCT01505608 - Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma | Biotech Hunter | Biotech Hunter