Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
This trial is active, not recruiting.
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2005|
|End date||April 2010|
|Trial size||36 participants|
|Trial identifier||NCT00126672, CDR0000440080, DFCI-04298, WYETH-C-0468H1-101899|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Loma Linda, CA||Tuberous Sclerosis Clinic at Loma Linda University Medical Center||no longer recruiting|
|Hartford, CT||Connecticut Children's Medical Center||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|New York, NY||New York University Medical Center||no longer recruiting|
|Cincinnati, OH||Cincinnati Children's Hospital Medical Center||no longer recruiting|
|Dallas, TX||University of Texas Southwestern Medical Center at Dallas||no longer recruiting|
Objective response as assessed by RECIST criteria
Toxicity as measured by NCI CTC
Male or female participants from 18 years up to 65 years old.
DISEASE CHARACTERISTICS: - Diagnosis of angiomyolipoma of the kidney secondary to tuberous sclerosis (TSC) or lymphangioleiomyomatosis (LAM)* - Tumor ≥ 2 cm by MRI NOTE: *Diagnosis of LAM by chest CT scan - No angiomyolipoma-related bleeding or impending bleed - No evidence of severe LAM, defined as dependence on continuous oxygen - Untreated renal cell carcinoma PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Hematocrit > 27% - ANC > 1,500 - Platelet count > 100,000 Hepatic - SGOT and SGPT < 2 times normal - Bilirubin < 2 times normal - Alkaline phosphatase < 2 times normal Renal - eGFR 30 or higher - No evidence of accelerating renal dysfunction - No acute renal failure Cardiovascular - No history of coronary artery disease Pulmonary - See Disease Characteristics Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No unstable seizures, defined as a recent change in seizure pattern or change in antiepileptic drug regimen - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 30 days since prior investigational agents - More than 6 months since prior vascular embolization therapy for treatment of kidney angiomyolipomas - No concurrent chronic use of diltiazem, ketoconazole, or rifampin - No other concurrent investigational agents
|Official title||A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients|
|Description||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.|
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