Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126672
First received: August 2, 2005
Last updated: February 1, 2010
Last verified: October 2008
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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 |
|---|---|---|
|
Nonmalignant Neoplasm |
Drug: sirolimus |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126672
Locations
| 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 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
| Study Chair: | Sandra Dabora, MD, PhD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sandra Dabora, Dana-Farber/Brigham and Women's Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00126672 History of Changes |
| Other Study ID Numbers: | CDR0000440080, DFCI-04298, WYETH-C-0468H1-101899 |
| Study First Received: | August 2, 2005 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
angiomyolipoma |
Additional relevant MeSH terms:
|
Neoplasms Angiomyolipoma Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Perivascular Epithelioid Cell Neoplasms Sirolimus Everolimus Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013