Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Sirolimus may be effective in treating chronic graft-versus-host disease that has not responded to previous systemic treatment.

PURPOSE: This phase II trial is studying how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease that has not responded to previous systemic treatment.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fred Hutchinson Cancer Research Center

Paul Carpenter

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00079183
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top