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Phase II Study of Calcitonin for Tumoral Calcinosis



Phase II Study of Calcitonin for Tumoral Calcinosis

For Condition: Calcinosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Children's Memorial Hospital, Chicago
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required
Total Enrollment: 9

Location and Contact Information:

Overall Study Official:
CraigLangman,  Study Chair,  Children's Memorial Hospital, Chicago

Children's Memorial Hospital, Chicago
Chicago,  Illinois,  60614
United States
 


Additional Information:
Study ID Numbers:
  199/11925;  NU-477
Study Start Date: November 1992
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004358

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