Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
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.
;
Primary Purpose: Treatment
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