Phase II Study of Calcitonin for Tumoral Calcinosis

Overview

OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment

Detailed Description

PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered. Patients are followed for disease progression and tumor recurrence.

Interventions

  • Drug: calcitonin

Participating in This Clinical Trial

PROTOCOL ENTRY CRITERIA: –Disease Characteristics– Histologically confirmed tumoral calcinosis –Prior/Concurrent Therapy– Prior surgical resection of calcinotic lesion required

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Center for Research Resources (NCRR)
  • Collaborator
    • Ann & Robert H Lurie Children’s Hospital of Chicago
  • Overall Official(s)
    • Craig B. Langman, Study Chair, Ann & Robert H Lurie Children’s Hospital of Chicago

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