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A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis


N/A
18 Years
N/A
Not Enrolling
Both
Radiation Fibrosis

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Trial Information

A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Kevin Camphausen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB

Authority:

United States: Federal Government

Study ID:

CDR0000068675

NCT ID:

NCT00020631

Start Date:

October 2001

Completion Date:

October 2007

Related Keywords:

  • Radiation Fibrosis
  • radiation fibrosis
  • Fibrosis
  • Radiation Pneumonitis

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182