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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00126672 |
Purpose
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 | Intervention | Phase |
|
Precancerous/Nonmalignant Condition |
Drug: sirolimus |
Phase II |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Sirolimus |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients |
| Estimated Enrollment: | 35 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of angiomyolipoma of the kidney secondary to tuberous sclerosis (TSC) or lymphangioleiomyomatosis (LAM)*
No evidence of severe LAM, defined as either of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| Tuberous Sclerosis Clinic at Loma Linda University Medical Center | Recruiting | ||||
| Loma Linda, California, United States, 92350 | |||||
| Contact: Stephen Ashwal, MD 909-558-2383 | |||||
| United States, Connecticut | |||||
| Connecticut Children's Medical Center | Recruiting | ||||
| Hartford, Connecticut, United States, 06106 | |||||
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |||||
| United States, Massachusetts | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |||||
| United States, New York | |||||
| New York University Medical Center | Recruiting | ||||
| New York, New York, United States, 10016 | |||||
| Contact: Daniel K. Miles, MD 212-263-8318 | |||||
| United States, Ohio | |||||
| Cincinnati Children's Hospital Medical Center | Recruiting | ||||
| Cincinnati, Ohio, United States, 45229-3039 | |||||
| Contact: David Franz, MD 513-636-4222 david.franz@chmcc.org | |||||
| United States, Texas | |||||
| University of Texas Southwestern Medical Center at Dallas | Recruiting | ||||
| Dallas, Texas, United States, 75390 | |||||
| Contact: Arthur I. Sagalowsky, MD 214-645-8797 arthur.sagalowsky@utsouthwestern.edu | |||||
| Dana-Farber Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Sandra Dabora, MD, PhD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000440080, DFCI-04298, WYETH-C-0468H1-101899 |
| First Received: | August 2, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00126672 |
| Health Authority: | Unspecified |
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