Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.

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

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: The LAM Foundation; Tuberous Sclerosis Alliance
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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