Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
The goal of this study is to determine whether thalidomide can stop the progression of fibrosis in IPF.
The primary objective of this study is to determine the safety, feasibility and efficacy of 400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary fibrosis (IPF) who have failed or are not candidates for treatment with corticosteroids and/or cytotoxic drugs.
The study population will consist of patients with biopsy-proven moderate to severe IPF who have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic drugs.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide|
- To determine the safety, feasibility and efficacy of 400 mg of thalidomide administered daily for one year in patients with IPF who have failed or are not candidates for treatment with corticosteroids and/or cytotoxic drug.
- The efficacy of thalidomide in preventing progressive pulmonary fibrosis and clinical deterioration measured objectively with changes in PFTs and radiographs as well as with dyspnea scales and quality of life measures.
|Study Start Date:||October 2003|
|Study Completion Date:||July 2007|
This is an unmasked Phase II, safety and efficacy trial of subjects with biopsy-proven IPF who have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic drugs. The study doctors are interested in studying the effects of the oral drug Thalomid(R) on IPF. Thalomid(R) (thalidomide) is an approved medication for Hansen's disease (leprosy). It is know to have anti-inflammatory effects and effects on fibrosis. It is hoped that Thalomid(R) may prevent progression of IPF.
Thalidomide is investigational for this use, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.
The age range for this study is 50-80 years, inclusive. There are 6 visits over the 12 month period. These visits include physical exams, pregnancy tests (if applicable), several symptom scales and questionnaires about your pulmonary fibrosis, pulmonary function testing, x-rays,peripheral nerve testing, and blood tests including arterial blood gas measurements. You will be given the medication in capsule form every 28 days for a year. There is a set schedule for increasing the doses of the thalidomide every 2 weeks until it reaches the 400 mg. dose that is being studies. A stool softener is also provided for each participant.
All subjects must read, sign and follow a manual of precautions prepared by Celgene, the manufacturer of Thalomid(R), before enrolling in this study. This manual, containing the S.T.E.P.S.(R) precautions, will be given to all participants.
This study is being conducted at the Johns Hopkins Medical Institutions located in Baltimore, Maryland.
|United States, Maryland|
|Johns Hopkins School of Medicine|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Maureen R Horton, M.D.||Johns Hopkins School of Medicine|