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Phase II Study of Sirolimus as Secondary Treatment for Patients With Chronic Graft-Versus-Host Disease Who Had An Inadequate Response to Prior Systemic Treatment
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment
Basic Trial Information
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Protocol IDs
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Phase II
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Supportive care
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Closed
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Any age
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NCI
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FHCRC-1706.00
NCT00079183
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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.
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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - See Disease Characteristics
- Concurrent prednisone allowed
Radiotherapy Surgery 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 50,000/mm3
Hepatic Renal 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
Expected Enrollment A total of 39 patients will be accrued for this study within 3 years. Outcomes Primary Outcome(s)Benefit
Secondary Outcome(s)Safety
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.
Trial Contact Information
Trial Lead Organizations Fred Hutchinson Cancer Research Center | | | | Paul Carpenter, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-Versus-Host Disease | | | Trial Start Date | | 2002-04-15 | | | Registered in ClinicalTrials.gov | | NCT00079183 | | | Date Submitted to PDQ | | 2004-01-28 | | | Information Last Verified | | 2006-09-17 | | | NCI Grant/Contract Number | | CA15704, CA100170, CA18221 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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