Medical Treatment of "High-Risk" Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response based on evaluation of symptom assessment, tumor measurements, and MRI studies - Toxicity of treatment combinations based upon laboratory studies and physical examination
Monthly physical exam first three months and then every three months after, MRI's will occur at baseline, 6, 12 and 24 months.
Albert S Cornelius, MD
Helen DeVos Children's Hospital
United States: Institutional Review Board
|Helen DeVos Children's Hospital||Grand Rapids, Michigan 49503|