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Home > "A" Clinical Trials Conditions > Autologous Stem Cell Transplant For Systemic Sclerosis  Autologous Stem Cell Transplant For Systemic Sclerosis
Autologous Stem Cell Transplant For Systemic Sclerosis
For Condition: Scleroderma, Systemic
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , University of Pittsburgh Cancer Institute,Amgen,Sangstat Medical Corporation
Synopsis: Patients with systemic sclerosis undergo tests,sign informed consent. Patients are admitted to hospital for a day of chemotherapy. Patients go home and receive a shot of G-CSF for about 10 days, then a procedure called Leukapheresis begins and is done as outpatient for up to 4 days. Chemotherapy is given for 5 days. The doses of chemotherapy will be increased after every three patients if there are no serious side effects. Thymoglobulin, an immunosuppressing drug, will be given for 3 days. On day 0 patient receive infusion of stem cells. It will take 2-4 weeks to recover from side effects of this treatment. Patient Involvement:Patients must be stay in the Pittsburgh area for their treatment, are required to use appropriate birth control to prevent pregnancy.Patients will have blood sample 16 times during first 2 years of treatment and return to Pittsburgh 12, 18, and 24 months after the transplant to be evaluated and to give blood samples.
Details: Patients with severe systemic sclerosis will undergo a prestudy evaluation to determine if they meet the eligibility requirements. They will then sign informed consent. Central line placement will be followed by mobilization chemotherapy with Cyclophosphamide 2000mg/m2 over 24 hours. Mesna 2000mg/m2 will be given for 48 hours as a bladder protectant. Patients will receive G-CSF (10mcg/kg/day) for about 10 days. When the WBC is greater than 2500 cells/mm3, Leukapheresis will begin and continue daily until a target dose of 5x10e6 CD34+/kg is achieved, for a maximum of 4 days. Treatment will then begin on a Monday and patients will receive Fludarabine 25mg/m2/day followed by Cyclophosphamide for 5 days, Day -7 to Day -3. Cy doses will begin at 200mg/m2/day and escalate in cohorts of three patients in 200mg/m2/day increments, to a maximum of 800mg/m2/day. Thymoglobulin will be administered IV at a dose of 2.5mg/kg/day from Day-5 to Day -3. On day 0 patients will receive an infusion of T-cell depleted CD34-selected autologous peripheral progenitor cells. Patient Involvement: Patients must be willing to stay in the Pittsburgh area for their treatment. They also will be required to use appropriate birth control to prevent pregnancy. Patients will be required to have blood sample 16 times during the first 2 years of treatment and to return to Pittsburgh 12, 18, and 24 months after the transplant to be evaluated and to give blood samples.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: - ECOG performance status of 0,1,2. - Adequate organ function as manifested by: ANC >1500/uL and platelets >/= 50,000/uL. - Creatinine 1.5 mg/dL and >/= 2.0 mg/dL, measured creatinine clearance must be >/= 60cc/min. - Bilirubin - Systolic ejection fraction documented by Muga >40%. - DLCO and FVC >/= 50% of predicted values. - Absence of small malabsorption syndrome. - Willingness to participate in all portions of the protocol, including pharmacodynamic and ancillary immunologic studies, and patient care follow-up visits at this institution. - Written informed consent. - Negative pregnancy test, nonlactating, and using effective means of contraception if of childbearing potential. Exclusion Criteria: - Immunosuppressive therapy, other than steroids within 4 weeks. - Patients with active infections, HIV positive by serology or Hepatitis C positive.
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
AndrewYeager, Study Chair, UPMC Health System
UPMC Health System 200 Lothrop Street *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Carol Blair 412-383-8672
Additional Information:
Study ID Numbers: NIAMS-047; N01 AR-9-2239
Study Start Date: July 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040651
Other Scleroderma, Systemic Studies:
1. Study of Silicone-Associated Connective Tissue Diseases
2. Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma
3. Six month clinical research study for patients with moderate or severe dry eye syndrome
4. Autologous Stem Cell Transplant For Systemic Sclerosis
Related Studies:
Other Scleroderma, Systemic Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Autologous Stem Cell Transplant For Systemic Sclerosis
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