Medical Treatment of "High-Risk" Neurofibromas

Status Completed

Clinical Trial Summary

Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. This study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.

Clinical Trial Description

The study's design involves treating eligible patients with a combination of celecoxib and pegylated interferon alpha-2b. If the patients have at least a partial response after six months, they may continue on the same treatment for up to two years. If the patient experiences less than a partial response, or has progressive disease after six months of therapy, then vincristine and temozolomide will be added to the celecoxib and interferon alpha-2b backbone. Response to treatment will be assessed after a minimum of six months, presuming the patient has not experienced progressive disease. Total duration of therapy on study is two years for any individual treatment plan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00846430
Study type	Interventional
Source	Spectrum Health Hospitals
Contact
Status	Completed
Phase	Phase 2
Start date	October 2008
Completion date	May 2017

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
Completed	`NCT00352599` - Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)	Phase 1
Completed	`NCT05005845` - NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)	Phase 2
Completed	`NCT03531814` - Medication Adherence in Children, Adolescents and Adults With Neurofibromatosis Type 1(NF1) on Clinical Treatment Trials	N/A
Completed	`NCT03433183` - SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors	Phase 2
Recruiting	`NCT05331105` - HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	Phase 2
Completed	`NCT03310996` - Non-invasive Stimulation in Neurofibromatosis Type 1	N/A
Recruiting	`NCT03406208` - Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing	N/A
Not yet recruiting	`NCT05849662` - A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia	Phase 1/Phase 2
Recruiting	`NCT04750928` - Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas	Phase 1/Phase 2
Not yet recruiting	`NCT06262113` - A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1	N/A
Active, not recruiting	`NCT04924608` - Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas	Phase 3
Recruiting	`NCT02544022` - Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
Recruiting	`NCT04941027` - Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1
Completed	`NCT02153931` - Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
Completed	`NCT05196854` - Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1	N/A
Active, not recruiting	`NCT01650142` - Modifying Genes in Neurofibromatosis 1	N/A
Completed	`NCT05377008` - Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1	N/A
Completed	`NCT04879160` - Systematically Assessing Changes in Plexiform Neurofibroma Related Disfigurement From Photographs of Subjects With Neurofibromatosis Type 1 on a Phase 2 Clinical Trial
Recruiting	`NCT05735717` - MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies	Phase 2