Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients|
- Objective response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|