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Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment



Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment

For Condition: Graft Versus Host Disease,Cancer
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Sirolimus may be effective in treating chronicgraft-versus-host disease that has not responded to previous systemic treatment. PURPOSE: Phase II trial to study the effectiveness of sirolimus as secondary therapy in treating patients who have chronic graft-versus-host disease that has not responded to previous systemic treatment.
Details: OBJECTIVES: - Determine the safety of sirolimus as secondary treatment for patients with chronic graft-versus-host disease who had an inadequate response to prior systemic treatment. - Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label study. Patients continue on oral prednisone and oral cyclosporine OR tacrolimus. Patients also receive oral sirolimus once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed chronic graft-versus-host disease (GVHD) - Inadequate response to prior treatment - Requires secondary systemic therapy as a result of 1 of the following: - Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ - Development of signs or symptoms of chronic GVHD in a previously uninvolved organ - No improvement after 3 months of primary treatment - Continued need for at least 1.0 mg/kg/day of prednisone for more than 2 months without qualifying for type of donor, graft, or conditioning regimen - No persistent or recurrent malignancy, including histologically confirmed myeloma or lymphoma - Patients with bcr/abl detected by polymerase chain reaction assay as the only evidence of persistent chronic myeloid leukemia allowed PATIENT CHARACTERISTICS: Age - Any age Performance status - Not specified Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 50,000/mm^3 Hepatic - Not specified Renal - Not specified Immunologic - No fungal or viral infection without radiographic evidence of improvement during continued appropriate antimicrobial therapy - No cytomegalovirus antigenemia unresponsive to antiviral therapy - No active disseminated varicella-zoster viral infection with persistent non-crusted lesions Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to tolerate oral medicine - No prior hypersensitivity to sirolimus PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - Concurrent prednisone allowed Radiotherapy - Not specified Surgery - Not specified Other - No concurrent systemic immunosuppressive medications except cyclosporine or tacrolimus - No concurrent grapefruit juice - No concurrent ketoconazole or voriconazole - No concurrent topical immunosuppressive treatment for chronic GVHD allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulCarpenter,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109-1024
United States
Recruiting Paul  Carpenter 206-667-3786


Additional Information:
Study ID Numbers:  CDR0000355110;  FHCRC-1706.00
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079183

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