Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

N/ACompletedNCT00020631

National Cancer Institute (NCI)

Overview

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: * Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis. 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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Conditions

Radiation Fibrosis

Interventions

pirfenidoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Range of motion * Strength * Edema * Swallowing * 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: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Hepatitis B and C negative Renal: * Not specified Other: * HIV negative * No evidence of second primary cancer * No life-threatening situation requiring rehabilitation intervention * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent anticancer immunotherapy Chemotherapy: * No concurrent anticancer chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * No concurrent anticancer radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer investigational agents * Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.