Use of Tamoxifen in Systemic Mastocytosis

April 9, 2020 updated by: Joseph Butterfield, Mayo Clinic

Treatment of Systemic Mastocytosis With Tamoxifen

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Not desired

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with systemic mastocytosis having up to 20% bone marrow involvement or clinical symptoms not controlled on current medications.

Description

Inclusion Criteria:

  • Systemic Mastocytosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 40mg/day and the duration of treatment will be for one year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Joseph H Butterfield, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 28, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

December 25, 2007

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2506-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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