A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
- Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with
unresectable plexiform neurofibroma. (Dose escalation portion of study closed to
accrual as of 2/2005.)
- Determine the toxicity profile of this drug in these patients.
- Obtain, preliminary, information about the efficacy of this drug in these patients.
- Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in
patients treated with this drug.
- Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.
OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study
closed to accrual as of 2/2005.)
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1
of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Primary Purpose: Treatment
Brigitte C. Widemann, MD
National Cancer Institute (NCI)
United States: Federal Government
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Memorial Hospital - Chicago||Chicago, Illinois 60614|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|