PROTOCOL OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified
according to gender and by position of the lesion (periorbital vs nonperiorbital).
All patients receive oral prednisone daily for 3 weeks. Patients are then randomized to
receive either placebo or leuprolide IM every 3 weeks, while continuing oral prednisone.
Tumors are assessed at 1, 3, and 6 weeks. If the tumor is not responding, the leuprolide
will be administered every 2 weeks. Tumors are reassessed at 3 and 6 months, at which point
the treatment is stopped. Responding patients are observed every 3 weeks for 3 months. If
the tumor begins to grow again, leuprolide may be administered for another 3 months.
Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy,
repeat the leuprolide or prednisone therapy, or undergo surgical excision.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Lois Hodgson Smith
Children's Hospital Boston
United States: Federal Government