Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 to 65 | NCI, Other | CDR0000440080 DFCI-04298, WYETH-C-0468H1-101899, NCT00126672 |
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.
Further Study Information
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 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
Trial Lead Organizations/Sponsors
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
National Cancer Institute| Sandra Dabora |  | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00126672
Information obtained from ClinicalTrials.gov on December 14, 2011
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