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Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis - NCT00282438-60611(Clinical Trial 136690)



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City:  Chicago
State:  
IL
Zip Code: 60611
Conditions: Sarcoidosis
Purpose: Sarcoidosis is a disease believed to be due to immune cells, cells which normally protect the body, but are now attacking lungs, heart, nerves, or other organs or systems within the body. As a result, the affected organs or systems fail to work properly causing difficulty breathing; heart failure; inability of the nerves to respond properly causing numbing, tingling, pain, and progressive muscle weakness; or other symptoms depending on the organ or body system involved. The likelihood of progression of this disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing this disease), followed by return of the previously collected blood stem cells will stop the progression of sarcoidosis. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body.
Study summary:
Criteria: Inclusion Criteria: 1. Age > or = 16 years and < or = 72 years at the time of pretransplant evaluation. 2. Definitive diagnosis of sarcoidosis in pathologic specimen. 3. Patients who failed to respond to conventional treatment of at least 3 months duration with corticosteroids (equivalent dosage of prednisone 1.0mg/kg/day to start). Patients must also have failed two or more of the followings: TNF inhibitors (etanercept, infliximab), methotrexate, azathioprine, 6-MP, cyclosporin, tacrolimus, mycophenolate mofetil, gold, dapsone, colchicine, chloroquine/hydroxychloroquine or any other immunosuppressive or modulating drugs. 4. Failure of therapy defined by (not caused by unrelated conditions) any one of following: - Progressive pulmonary disease (stage II or III) defined by decline in pulmonary function (DLCo, VC or FEV1) of 15% or more over 12 months. - Progressive CNS disease (worsening symptoms such as paraparesis or medically refractory seizure). - Persistent peripheral neuropathy (one of following): 1. Persistent muscle weakness Grade 3/5 or worse (MRC) in at least one movement (e.g. ankle dorsiflexion) in two limbs. 2. Persistent cranial nerve involvement such as persistent facial diplegia. 3. Persistent incapacitating sensory loss (e.g. gait ataxia, falls > 1/month). - Progressive loss of vision. - Persistent hypercalcemia. 5. Cardiac sarcoidosis that is proven by cardiac biopsy (patients with proven cardiac sarcoidosis do not need to meet the eligibility criteria listed in #'s 3 and 4 above). Exclusion Criteria: 1. Alternative diagnosis. 2. Noncompliance to medical care. 3. > 10 pack-year history of cigarette smoking if lung disease is the major problem. 4. Poor performance (PS) status (ECOG >2) at the time of entry, unless decline of PS is due to the disease itself. 5. Significant end organ damage such as: 1. Overt congestive heart failure (NYHA Class III or IV). 2. Active ischemic heart disease, s/p myocardial infarction within 6 months, s/p unstable angina within 3 months, s/p CVA within 6 months, s/p hospitalization for CHF within 3 months. 3. Untreated life-threatening arrhythmia. 4. Pulmonary hypertension > 40 mmHg. 5. End-stage lung disease (TLC < 55%, FVC < 55%, or DLCO < 40% of predicted value). 6. Serum creatinine > 2.5 or creatinine clearance < 30 ml/min. 7. Liver cirrhosis, transaminases > 3x normal or bilirubin > 2.0 unless due to Gilbert's disease.
Study is available at: Northwestern University, Feinberg School of Medicine
Chicago, IL 60611
United States

Primary Contact:
Dzemila Spahovic, MD
Email: d-spahovic@northwestern.edu
Phone: 312-908-0059
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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