Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00020631


Primary Contact:

Principal Investigator
Kevin Camphausen, MD
NCI - Radiation Oncology Branch; ROB


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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