Clinical Trial: Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
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.
Detailed Summary:
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Sponsor: Dana-Farber Cancer Institute
Current Primary Outcome:
- Objective response as assessed by RECIST criteria
- Toxicity as measured by NCI CTC
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: August 2, 2005
Date Started: June 2005
Date Completion:
Last Updated: February 1, 2010
Last Verified: October 2008
