The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on you. The study will be done with female patients who have been diagnosed with Systemic Lupus Erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after your intravenous cyclophosphamide treatment has been completed.

This study is being conducted at 7 sites across the United States (New York, Chicago, Milwaukee, Columbus, Seattle, Los Angeles, Cincinnati). A total of 50 patients will participate in this study.

Each patient will be randomized (assigned) to one of 5 groups. Randomization means that you are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group.

Condition	Intervention	Phase
SLE Systemic Lupus Erythematosus	Drug: Triptorelin palmoate (Trelstar Depot)	Phase II

Further Study Details: 

Primary Outcomes: To Determine the dose of Triptorelin that is will maintain complete ovarian suppression between monthly injections
Secondary Outcomes: To optimize the time interval at triptorelin injection and infusion of cyclophosphamide.
Expected Total Enrollment:  50

Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney, brain, skin and lungs. Cyclophosphamide is a very effective medication to treat lupus, but it can damage the ovaries (pair of reproductive organs).

Only female lupus patients may participate in this study.

Ages Eligible for Study:  9 Years   -   21 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Females under the age of 21 and non-pregnant
• Tanner stage of 2 or above as determined by physical examination of breast stage
• Diagnosis with SLE using the updated American College of Rheumatology (ACR) Classification Criteria for SLE 1
• Severe SLE requiring cyclophosphamide therapy
• Bone mineral density z-score > - 2.0
• Must be using a medically acceptable form of birth control during the study and must not be pregnant at the screening visit
• No clinically significant abnormal findings other than those consistent with the diagnosis of childhood-onset SLE (cSLE) on the physical examination, medical history or clinical laboratory results during screening
• Currently on any combination of medication but must not have been treated with more than one dose of cyclophosphamide or other gonadotoxic medications in the past
• Voluntary consent or, if under the age of consent, assent to participate in this study with permission by a legal guardian

Exclusion Criteria:

• Male patients of any age
• Female patients with a Tanner stage of 1
• Positive blood pregnancy test at screening or taking oral or injectable birth-control medications
• Prior exposure to more than one dose of gonadotoxic medications including cyclophosphamide
• History of allergic or adverse response to triptorelin -Diagnosed with hypogonadism prior to cyclophosphamide exposure
• Acutely life-threatening disease activity that prohibits inclusion in a clinical trial
• History of clinically significant gastrointestinal tract, renal, hepatic, endocrine, oncologic, pulmonary (asthma accepted), or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, depression, psychosis, or any other non-cSLE condition, which in the opinion of the physician, would jeopardize the safety of the subject or impact the validity of the study results
• Patient age 18 years of younger with severe depression as defined by a CDI (Children’s Depression Inventory) score of > 23 or a patient age 19 – to 21 years with severe depression as defined by a BDI (Beck’s Depression Inventory) score > 29
• Patient admits to suicidal thoughts at screening visit
• Bone mineral density lower than z = -2.0.

Please refer to this study by ClinicalTrials.gov identifier  NCT00124514

Hermine I Brunner, M.D. M.Sc.      513-636-7275    hermine.brunner@cchmc.org
Shannen L Nelson, RN, BSN      513-636-5484    Shannen.Nelson@cchmc.org

California
      Children’s Hospital of Los Angeles, Los Angeles,  California,  90027,  United States; Recruiting
Illinois
      Children''''s Memorial Hospital, Chicago,  Illinois,  60614,  United States; Recruiting
New York
      Morgan Stanley Children''''s Hospital of New York, New York,  New York,  10032,  United States; Recruiting
Ohio
      Cincinnati Children''''s Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting
      Columbus Children''''s Hospital, Columbus,  Ohio,  43205,  United States; Recruiting
Wisconsin
      Children’s Hospital of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study chairs or principal investigators

Hermine I Brunner, M.D. M.Sc.,  Principal Investigator,  Children''''s Hospital Medical Center - Cincinnati   

Study ID Numbers:  FD-R-00239
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124514
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02