Status:
COMPLETED
Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Novartis
Conditions:
Tuberous Sclerosis
Subependymal Giant Cell Astrocytoma
Eligibility:
All Genders
3+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
Tuberous Sclerosis Complex (TSC)is a genetic disorder with a birth incidence of approximately one in six thousand. Five to twenty percent of patients with TSC will develop astrocytoma, a slowly progre...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00411619
Start Date
January 1 2007
End Date
January 1 2014
Last Update
October 20 2014
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229