Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02718131

A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1) — NF107-BMP2  

NF1 Clinical Trial

Official title:
A Study of INFUSE Bone Graft (Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis 1 (NF1)

Clinical Trial Summary

The current study proposes adding BMP-2 (INFUSE), an anabolic agent, at the surgical site of TPA (tibial pseudarthrosis) repair in children with NF1, compared to a control group of patients treated surgically without BMP-2. The following Specific Aims will be addressed: 1) to determine if use of an osteogenic agent (BMP-2) at the time of surgical repair of TPA in NF1 patients will result in improved bone healing; 2) to document safety of BMP-2 in a pediatric NF1 population; and 3) to collect, process, and preserve biologic specimens at the time of surgery for future studies.

Clinical Trial Description

A randomized study will be performed by a multi-center group of the NF Consortium. A total of 54 patients will be randomized for treatment with or without INFUSE Bone Graft at the time of surgical repair. For all patients, a standard surgical procedure will be used, including: resection of pseudarthrosis tissue; placement of a rigid intramedullary rod; and placement of autogenous bone graft from iliac crest. For patients in the BMP group, the INFUSE device containing BMP-2 will in addition be applied intraoperatively to the osteotomy site. Fracture union will be determined by scoring of radiographs (RUST score) for cortical bone fusion and callus formation at the osteotomy site. RUST score at 12 months post-surgery will be the primary outcome measure to determine efficacy. Secondary measures will include determination of time to healing (months); quality of life measures; functional walking measures; and incidence of refracture after surgery. This study, once successfully completed, will determine if use of INFUSE Bone Graft improves healing of tibial pseudarthrosis in NF1 and will document safety issues. Regardless of results, the better performing of the two groups (control or BMP) will be able to serve as a much-needed control arm for future studies of additional targeted therapeutic agents for NF1-related bone disease. An international working group of orthopaedic surgeons and NF specialists has been formed and is committed to successful completion of this trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02718131
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Terminated
Phase N/A
Start date March 1, 2016
Completion date June 1, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01362803 - AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors Phase 1/Phase 2
Recruiting NCT06104488 - A Study of Avutometinib for People With Solid Tumor Cancers Phase 1
Recruiting NCT02964884 - Interventions for Reading Disabilities in NF1 Phase 2
Completed NCT00006435 - Study of Plexiform Neurofibromas in Neurofibromatosis Type 1
Completed NCT00684398 - Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I
Recruiting NCT05238909 - Developing Biomarkers of Plexiform Tumor Burden in Patients With Neurofibromatosis-Type 1
Active, not recruiting NCT04954001 - Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 Phase 1/Phase 2
Terminated NCT01402817 - Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas Phase 2
Completed NCT02101736 - Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults Phase 2
Recruiting NCT05913037 - FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas Phase 3
Not yet recruiting NCT05253131 - Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas Phase 2
Completed NCT01275586 - Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas Early Phase 1
Recruiting NCT06159166 - Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). Phase 1/Phase 2
Recruiting NCT04544007 - A Phase II Trial of Poly-ICLC for Low-Grade Gliomas Phase 2