Clinical Trial: Use of Tamoxifen in Systemic Mastocytosis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Treatment of Systemic Mastocytosis With Tamoxifen

Brief Summary: In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 20% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.

Detailed Summary: Not desired
Sponsor: Mayo Clinic

Current Primary Outcome: Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype. [ Time Frame: 1 year ]

up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be for one year.


Original Primary Outcome: Same as current

Current Secondary Outcome: Stability or improvement in biochemical markers of systemic mastocytosis [ Time Frame: 1 year ]

Stability or improvement in biochemical markers of systemic mastocytosis (serum tryptase, calcitonin, urinary N-methyl histamine and prostaglandin F2 excretion/24 hours, liver function studies, lactic dehydrogenase, complete blood count with leukocyte differential)


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: December 25, 2007
Date Started: February 2005
Date Completion: December 2014
Last Updated: August 11, 2014
Last Verified: August 2014