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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079183 |
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.
Condition | Intervention | Phase |
---|---|---|
Graft Versus Host Disease |
Drug: cyclosporine Drug: prednisone Drug: sirolimus Drug: tacrolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-Versus-Host Disease |
Study Start Date: | April 2002 |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed chronic graft-versus-host disease (GVHD)
Requires secondary systemic therapy as a result of 1 of the following:
No persistent or recurrent malignancy, including histologically confirmed myeloma or lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Paul Carpenter, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000355110, FHCRC-1706.00 |
Study First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00079183 |
Health Authority: | United States: Federal Government |
graft versus host disease |
Sirolimus Prednisone Cyclosporine Clotrimazole Graft versus host disease Miconazole |
Tioconazole Neoplasm Metastasis Graft vs Host Disease Tacrolimus Cyclosporins Homologous wasting disease |
Anti-Inflammatory Agents Anti-Infective Agents Antineoplastic Agents, Hormonal Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Antibiotics, Antineoplastic Hormones Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |