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

Primary Purpose

Radiation Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pirfenidone
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiation Fibrosis focused on measuring radiation fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
June 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020631
Brief Title
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
Official Title
A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Fibrosis
Keywords
radiation fibrosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pirfenidone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Camphausen, MD
Organizational Affiliation
NCI - Radiation Oncology Branch; ROB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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