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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Pirfenidone

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