Use of Tamoxifen in Systemic Mastocytosis

Systemic Mastocytosis Clinical Trial

Official title:

Treatment of Systemic Mastocytosis With Tamoxifen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334996
• Other study ID #: 2506-04
• Status: Completed
• Start date: February 2005
• Est. completion date: August 28, 2019

Study information

• Verified date: April 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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 40 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.

Description:

Not desired

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Systemic Mastocytosis

Exclusion Criteria:

• Current treatment with Imatinib mesylate, cladribine or interferon alpha.

Related Conditions & MeSH terms

• Mastocytosis
• Systemic Mastocytosis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype.	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 40mg/day and the duration of treatment will be for one year.	1 year
Secondary	Stability or improvement in biochemical markers of systemic mastocytosis	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)	1 year

External Links

•   Mayo Clinic Clinical Trials