RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.
OBJECTIVES: Primary * 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. Secondary * 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 the MTD. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
36
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
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