Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT00162760
Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
A Phase 2 study testing Thalidomide in people with Idiopathic Pulmonary Fibrosis (IPF), run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Thalidomide
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Thalidomide
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Maureen R Horton, M.D., Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162760
- Sponsor's protocol ID
- CG00519
- Status last verified
- Oct 2007
- First submitted
- 8 Sep 2005
- Last updated
- 22 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
- ClinicalTrials.gov ID
- NCT00162760
- Acronym / sponsor ID
- CG00519
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Oct 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Johns Hopkins Pulmonary \& Critical Care Medicine websiteLink provided by the sponsor.
- Pulmonary Fibrosis FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen R Horton, M.D. principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Idiopathic Pulmonary Fibrosis (IPF), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.