Trial Search Results
Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease
To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.
Stanford is currently not accepting patients for this trial.
- Drug: Sirolimus
- Drug: Prednisone
- Age ≥ 13 years
- Weight ≥ 40 kg.
- Biopsy or clinical presentation diagnostic of chronic GVHD >100 days following
allogeneic bone marrow/peripheral blood/umbilical cord blood transplantation that has
failed prior corticosteroid therapy or corticosteroid taper. In the event that
histological confirmation poses undue risk, clinical evaluation is sufficient.
- Women of child-bearing potential must have a negative pregnancy test before sirolimus
administration and agree to use a medically acceptable contraceptive throughout the
treatment period until 3 months after discontinuation of sirolimus.
- Any woman becoming pregnant during the treatment period must discontinue the use of
- Absolute neutrophil count (ANC) > 1000/mm³, unless receiving G-CSF to maintain
neutrophil count > 500/mm³.
- At the time of initiating sirolimus the cyclosporine trough level is recommended to be
< 100 mg/dl and FK506 level is recommended to be < 5 mg/dl. FK506 or cyclosporine is
to be discontinued soon after initiation of sirolimus.
- Karnofsky performance score ≥ 50 during pre-study screening.
- Written, signed, and dated informed consent
- Uncontrolled systemic infection
- Unstable disease states (i.e., hepatic failure, ventilatory-dependent respiratory
- Serum creatinine ≥ 3.0 mg/dL
- Platelet count ≤ 50,000/mm³
- History of Post-transplant microangiopathic hemolytic anemia
- Uncontrolled hyperlipidemia
- Use of any investigational drug within 4 weeks of entry into the study
- Use of methotrexate or antibody therapies within 24 hours of sirolimus administration
- Inability to tolerate oral therapy for any reason
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study
- Known hypersensitivity to macrolide antibiotics
Ages Eligible for Study
13 Years - N/A
Genders Eligible for Study