Precancerous Condition Clinical Trial
Official title:
Phase I Trial Of Pirfenidone In Children With Neurofibromatosis Type 1 And Plexiform Neurofibromas
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. Pirfenidone may slow the growth or prevent further
development of plexiform neurofibromas.
PURPOSE: Phase I trial to study the effectiveness of pirfenidone in treating young patients
who have neurofibromatosis type 1 and plexiform neurofibroma.
OBJECTIVES:
- Determine the maximum tolerated dose or "comparable dose" of pirfenidone in pediatric
patients with neurofibromatosis type 1 and inoperable, symptomatic plexiform
neurofibromas.
- Determine the toxic effects of this drug in these patients.
- Determine the plasma pharmacokinetics of this drug in these patients.
- Determine, preliminarily, if this drug could be beneficial for pediatric patients with
refractory solid tumors.
- Assess the quality of life of patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive oral pirfenidone three times daily on days 1-28. Courses repeat every 28
days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pirfenidone until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline, before course 4, and then after every 6 courses.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 18 months.
;
Masking: Open Label, Primary Purpose: Prevention
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