Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment

• Status: Completed
• Trial end date: 2010-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center; Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of

• Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or

• Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or

• Absence of improvement after 3 months of primary treatment, or

• Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen

• Patient or guardian able and willing to provide informed consent

• Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration [FDA] requirement)

• Stated willingness of the patient to comply with study procedures and reporting requirements

• Stated willingness of the physician most involved in management of chronic GVHD (the "managing physician,") to comply with study procedures and reporting requirements

Exclusion Criteria:

• Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy

• Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy

• Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions

• Inability to tolerate oral medications

• Absolute neutrophil count (ANC) < 1500/uL

• Platelet count < 50,000/uL

• Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled

• Pregnancy

• Known history of hypersensitivity to sirolimus