Status:
COMPLETED
Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Clinical history consistent with IPF for greater than or equal to 3 months duration and less than 5 years.
- Documented IPF with UIP on histologic examination of surgical lung biopsy confirmed by study physician (RT).
- High resolution CT (HRCT) of chest consistent with IPF (bibasilar reticular abnormalities with minimal ground glass opacities) as determined by study physician (KMH).
- Failure to have \>/= 10% increase in FVC on prior adequate treatment with corticosteroids and/or cytotoxic drugs, or intolerance to these drugs precluding use.
- FVC \>/= 40% and \</= 90% predicted at screening.
- DLCo \>/= 25% predicted at screening
- Oxygen saturation \>/= 88% on room air or \</= 2L oxygen at screening.
- Age 50-80 inclusive
- Ability to understand and sign informed written consent form and comply with study guidelines
Exclusion
- Known etiology of ILD (e.g. sarcoid, hypersensitivity pneumonitis, BOOP etc.)
- Clinically significant toxic or environmental exposure to respiratory irritants (e.g. drugs, asbestosis, radiation etc.)
- Diagnosis of collagen vascular disease.
- Obstruction on PFTs, defined as FEV1/FVC \< 0.6.
- Active infection
- End stage coronary artery disease, congestive heart failure or cor pulmonale
- History of significant peripheral vascular disease
- History of peripheral neuropathy
- History of clinically significant obstructive sleep apnea
- History of poorly controlled diabetes
- Pregnant or lactating women
- Abnormal laboratories as defined as: WBC \< 2300/mm3, HCT \< 30% or \>55%, PLT \< 100k/mm3. creatinine \>1.5, AST or ALT \> 3x normal, total bilirubin \> 1.5.
- Current enrollment in another protocol for IPF
- Prednisone use \>15 mg a day in 4 weeks prior to starting trial.
- Cytotoxic drugs (cyclophosphamide, azathioprine, colchicines, cyclosporine, interferon-gamma) 6 weeks prior to screening.
- Patients requiring chronic narcotic analgesic.
- Patients unable to give informed consent.
- Patients unable to comply with the requirements for the trial.
- Patients with known allergy/intolerance to thalidomide;
- Patients with a predicted life expectance less than 6 months.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00162760
Start Date
October 1 2003
End Date
July 1 2007
Last Update
June 22 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287