Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
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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.
| Condition | Intervention |
|---|---|
|
Radiation Fibrosis |
Drug: pirfenidone |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis |
| Study Start Date: | October 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Kevin Camphausen, MD | NCI - Radiation Oncology Branch; ROB |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00020631 History of Changes |
| Obsolete Identifiers: | NCT00014924 |
| Other Study ID Numbers: | CDR0000068675, NCI-01-C-0143 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
radiation fibrosis |
Additional relevant MeSH terms:
|
Fibrosis Radiation Pneumonitis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Lung Injury Radiation Injuries Wounds and Injuries Pirfenidone Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013