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Trial Information

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.

Inclusion Criteria

- Presence of hemangioma meeting at least one of the following criteria:
Vision-threatening because of induced astigmatism or occlusion of the visual axis or
proptosis Severe anatomic distortion compromising function of an organ or creating an
unacceptable cosmetic outcome Other complications, e.g., Kasabach-Merritt consumptive
coagulopathy, high-output heart failure, etc.

- No lesions that are clearly regressing before therapy

- No vascular malformations other than juvenile hemangiomas

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Principal Investigator

Lois Hodgson Smith

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Boston


United States: Federal Government

Study ID:




Start Date:

July 1993

Completion Date:

June 2000

Related Keywords:

  • Hemangioma
  • cardiovascular and respiratory diseases
  • hemangioma
  • rare disease
  • Hemangioma
  • Hemangioma, Capillary