Medical Treatment of "High-Risk" Neurofibromas
Neurofibromatosis 1
About this trial
This is an interventional treatment trial for Neurofibromatosis 1 focused on measuring Neurofibromas, Neurofibromatosis 1, Celecoxib, Celebrex, Peg-Interferon alpha-2b, PEG-Intron, Temozolomide, Temodar, Vincristine Sulfate, Oncovin
Eligibility Criteria
Inclusion Criteria:
- "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1
- 2-30 years old (minimum bodyweight of 10 kilograms)
- Adequate renal function
Exclusion Criteria:
- Previously untreated active optic glioma
- History of any previous allergy to study medications
- History of ischemic vascular disease
- Pregnancy / Breast feeding
Sites / Locations
- Helen DeVos Children's Hospital
Arms of the Study
Arm 1
Experimental
Open-Label Intervention
This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study.