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Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162760
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 22, 2010
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date June 22, 2010
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
Official Title  ICMJE Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis (IPF)
Intervention  ICMJE Drug: Thalidomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 11, 2005)
19
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162760
Other Study ID Numbers  ICMJE CG00519
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Maureen R Horton, M.D. Johns Hopkins School of Medicine
PRS Account Johns Hopkins University
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP