Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide

NCT00162760 | Completed Phase 2

• 1 other identifier: CG00519
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Links

• Johns Hopkins Pulmonary \& Critical Care Medicine website
• Pulmonary Fibrosis Foundation

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Maureen R Horton, M.D.

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: October 1, 2003
• Study Completion: July 1, 2007
• Last Updated: June 22, 2010

Record last verified: 2007-10

Locations

US (1)