Clinical Trials Logo
  1. Home
  2. Plexiform Neurofibromas
  3. NCT02177825

Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform Neurofibromas

Plexiform Neurofibromas Clinical Trial

Official title:
Phase II Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform Neurofibromas

Clinical Trial Summary

This phase II trial will test the hypothesis that inhibition of c-kit signalling pathways in pediatric patients with Neurofibromatosis Type I(NF-1) and progressing plexiform neurofibroma will result in objective reduction and/or inhibition of plexiform neurofibromas progression.

This will be a Phase II study of imatinib mesylate given orally. Patients with stable or responding disease may receive the drug for a period not exceeding one year.

Clinical Trial Description

Clinical objectives

1. Demonstrate the clinical benefit of imatinib in a pediatric patient population with progressing and metabolically active plexiform neurofibromas (NF)

2. Demonstrate the need or not to pursue treatment for more than a year in responders to imatinib

Biological studies objectives

1. Identify biological markers of plexiform neurofibroma progression and response to treatment

2. Identify biological markers of mast cell responses to imatinib, given that mast cells are required for tumorigenesis and are a target for imatinib

Imaging studies objectives

Using 18-Fluorodeoxyglucose-positron Emission Tomography (FDG PET/CT):

1. Identify imaging characteristics of progressing plexiform neurofibromas

2. Assess the role of F18-FDG PET/CT in comparison with CT/MRI to evaluate response to imatinib ¸

Pharmacological study

1. Evaluate trough plasma levels of imatinib and its active metabolite (NDMIL N-desmethyl imatinib) achieved in this pediatric population

2. Identify potential correlation between imatinib (and NDMI) trough levels achieved and clinical response ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02177825
Study type Interventional
Source St. Justine's Hospital
Contact
Status Terminated
Phase Phase 2
Start date June 2014
Completion date March 1, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05331105 - HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Phase 2
Recruiting NCT02544022 - Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
Recruiting NCT02777775 - Targeting the Mechanisms Underlying Cutaneous Neurofibroma Formation in NF1: A Clinical Translational Approach.
Completed NCT00006435 - Study of Plexiform Neurofibromas in Neurofibromatosis Type 1
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
Completed NCT02471339 - Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain Phase 3
Recruiting NCT05683678 - US Selumetinib Registry
Recruiting NCT02644512 - MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Phase 2
Withdrawn NCT05825365 - Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, Phaseâ…¡, Double-Blinded, Placebo-Controlled Study Phase 2