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| Descriptive Information Fields | |||||
| Brief Title † | Sirolimus in Treating Patients With Angiomyolipoma of the Kidney | ||||
| Official Title † | A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with angiomyolipoma of the kidney. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients receive oral sirolimus once daily for 12 months in the absence of unacceptable toxicity. After completion of study treatment, patients are followed at 6 months and 1 year. PROJECTED ACCRUAL: A total of 13-35 patients will be accrued for this study within 3-30 months. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Objective response as assessed by RECIST criteria [ Designated as safety issue: No ] Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Precancerous/Nonmalignant Condition | ||||
| Intervention † | Drug: sirolimus | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 35 | ||||
| Start Date † | June 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00126672 | ||||
| Organization ID | CDR0000440080 | ||||
| Secondary IDs †† | DFCI-04298, WYETH-C-0468H1-101899 | ||||
| Study Sponsor † | Dana-Farber Cancer Institute | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | August 2, 2005 | ||||
| Last Updated Date | July 23, 2008 | ||||