A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.
PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.
OBJECTIVES:
OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS:
Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities)
At least moderate impairment in at least 1 of the following principal functional abilities:
Prior radiation for cancer received more than 6 months ago
No evidence of recurrent or metastatic cancer
No history of collagen vascular disease
No positive antinuclear antibody
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: