Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex

Completed · Phase 1/Phase 2

Conditions studied: Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma

In brief

The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma) The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.

Key facts

Study ID

NCT00411619

Run by

Children's Hospital Medical Center, Cincinnati

People needed

28

Starts

2007-01-01

Expected to finish

2014-01-01

Last updated by the study team

2014-10-20

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age three years and older
• If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. In the extension phase, all females of child bearing potential will be required to take monthly home pregnancy tests and record results on a provided diary card.
• Clinically definite diagnosis of tuberous sclerosis (modified Gomez criteria or positive genetic test)
• Presence of giant cell astrocytoma as defined by imaging characteristics and serial increase in size of lesion on 2 or more MRI scans
• Adequate renal function (creatinine < 1.5 mg/dl)

You may not qualify if…

• Serious intercurrent medical illness or other uncontrolled medical disease which could compromise participation in the study
• Significant hematologic or hepatic abnormality
• Continuous requirement for supplemental oxygen
• Intercurrent infection at initiation of everolimus
• Embolization of angiomyolipoma within one month; any other recent surgery within 2 months of initiation of everolimus
• Pregnant or lactating women
• Use of an investigational drug within the last 30 days
• Must be adequately recovered from the acute toxicities of any prior therapy
• Clinical evidence of impending herniation or focal neurologic deficit related to the subject's astrocytoma
• Unwilling or unable to use highly effective contraception

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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