Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
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|ClinicalTrials.gov Identifier: NCT00126672|
Recruitment Status : Unknown
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 4, 2005
Last Update Posted : February 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonmalignant Neoplasm||Drug: sirolimus||Phase 2|
- Determine the efficacy of sirolimus, in terms of objective response rate, in patients with angiomyolipoma of the kidney secondary to tuberous sclerosis (TSC) or lymphangioleiomyomatosis (LAM).
- Determine the toxicity of this drug in these patients.
- Determine changes in other TSC lesions (e.g., tubers, subependymal giant cell astrocytomas, facial angiofibromas, or kidney cysts) in patients with TSC treated with this drug.
- Determine changes in pulmonary disease in patients with LAM treated with this drug.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients|
|Study Start Date :||June 2005|
|Estimated Primary Completion Date :||April 2010|
- Objective response as assessed by RECIST criteria
- Toxicity as measured by NCI CTC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126672
|United States, California|
|Tuberous Sclerosis Clinic at Loma Linda University Medical Center|
|Loma Linda, California, United States, 92350|
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|New York University Medical Center|
|New York, New York, United States, 10016|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Sandra Dabora, MD, PhD||Dana-Farber/Brigham and Women's Cancer Center|