A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

November 30, 2014

Study Completion Date

December 31, 2015

Conditions
Neurofibromatosis Type 1
Interventions
DRUG

Sirolimus

This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry.

Trial Locations (9)

19096

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20892

National Cancer Institute (NCI), Bethesda

35294

The University of Alabama at Birmingham, Birmingham

60637

University of Chicago, Chicago

63110

Washington University, St Louis

84132

University of Utah, Salt Lake City

02115

Children's Hospital Boston, Boston

45229-4006

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

Boston Children's Hospital

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Children's National Research Institute

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of Chicago

OTHER

collaborator

University of Utah

OTHER

collaborator

Washington University School of Medicine

OTHER

lead

University of Alabama at Birmingham

OTHER