Sirolimus in Treating Patients With Angiomyolipoma of the Kidney

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

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