Status:
COMPLETED
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
The LAM Foundation
Tuberous Sclerosis Alliance
Conditions:
Tuberous Sclerosis
Lymphangioleiomyomatosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.
Detailed Description
The study design was an open label, phase I/II trial of sirolimus for one year followed by one year off therapy.Patients were seen at baseline,at two weeks to four weeks, and at 2,4,6,9,12,18 and 24 m...
Eligibility Criteria
Inclusion
- Diagnosed with angiomyolipomas and have either Tuberous Sclerosis complex or Lymphangioleiomyomatosis
- Between the gaes of 18 and 65 years
- Competency to voluntarily consent
- Clinically definite diagnosis of tuberous sclerosis or S-LAM
- Adequate contraception
- At least one angiomyolipoma of 1 cm or greater in largest diameter
Exclusion
- Use of continuous supplemental oxygen
- Concurrent infection
- Recent surgery
- Ongoing or planned pregnancy
- Lactation
- Use of an investigational drug within the last 30 days of study entrance
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00457808
Start Date
December 1 2002
End Date
March 1 2006
Last Update
April 9 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039