Medical Treatment of "High-Risk" Neurofibromas

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Treatments: Celecoxib; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Temozolomide; Vincristine

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