Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
With
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.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
