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Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome Clinical research trials and Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome. Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome



Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

For Condition: Systemic Lupus Erythematosus,Antiphospholipid Antibody Syndrome
Status: Recruiting
Sponsor(s): Johns Hopkins Oncology Center ,
Synopsis: OBJECTIVES: I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide. II. Determine the toxicity of this drug in these patients.
Details: PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover. Patients are followed monthly for 6 months, and then every 3 months thereafter.
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4 American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on SLEDAI OR Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy --Patient Characteristics-- Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times normal Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Ejection fraction at least 45% Pulmonary: FVC, FEV1, or DLCO at least 50% predicted Other: Not preterminal or moribund; not pregnant or nursing; fertile patients must use effective contraception
Total Enrollment: 35

Location and Contact Information:

Overall Study Official:
RobertBrodsky,  Study Chair,  Johns Hopkins Oncology Center

Johns Hopkins University School of Medicine *Recruiting*
Baltimore,  Maryland,  21205
United States
Recruiting Michelle  Petri 410-955-3823

Johns Hopkins Oncology Center *Recruiting*
Baltimore,  Maryland,  21231
United States
Recruiting Robert  Brodsky 410-955-2813


Additional Information:
Study ID Numbers:
  199/15673;  JHOC-J9717,JHOC-97022128
Study Start Date: April 1997
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010400

Other Antiphospholipid Antibody Syndrome Studies:
1. Drug Therapy in Lupus Nephropathy

2. Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus

3. Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus

4. Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus

5. Safety of Estrogens in Lupus: Birth Control Pills

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Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

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