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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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment Clinical research trials and Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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 Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment clinical trial. Human subjects often get the best healthcare available for their Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > 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
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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Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment
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