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Medical Treatment of "High-Risk" Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies


Phase 2
2 Years
30 Years
Open (Enrolling)
Both
Neurofibromatosis 1

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response based on evaluation of symptom assessment, tumor measurements, and MRI studies - Toxicity of treatment combinations based upon laboratory studies and physical examination

Outcome Time Frame:

Monthly physical exam first three months and then every three months after, MRI's will occur at baseline, 6, 12 and 24 months.

Safety Issue:

No

Principal Investigator

Albert S Cornelius, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helen DeVos Children's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2008-260

NCT ID:

NCT00846430

Start Date:

October 2008

Completion Date:

December 2010

Related Keywords:

  • Neurofibromatosis 1
  • Neurofibromas
  • Neurofibromatosis 1
  • Celecoxib
  • Celebrex
  • Peg-Interferon alpha-2b
  • PEG-Intron
  • Temozolomide
  • Temodar
  • Vincristine Sulfate
  • Oncovin
  • Neurofibroma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica

Name

Location
Helen DeVos Children's Hospital Grand Rapids, Michigan  49503