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Use of Tamoxifen in Systemic Mastocytosis

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ClinicalTrials.gov Identifier: NCT01334996
Recruitment Status : Unknown
Verified August 2014 by Mayo Clinic.
Recruitment status was:  Recruiting
First Posted : April 13, 2011
Last Update Posted : August 12, 2014
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Systemic Mastocytosis

Detailed Description:
Not desired

Study Design

Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Systemic Mastocytosis With Tamoxifen
Study Start Date : February 2005
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Systemic Mastocytosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334996


Contacts
Contact: Joseph H Butterfield, MD 507-284-9077 butterfield.joseph@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Joseph H Butterfield, MD    507-284-3783    butterfield.joseph@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph H Butterfield, MD Mayo Clinic
More Information

Additional Information:
Responsible Party: Joseph Butterfield M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01334996     History of Changes
Other Study ID Numbers: 2506-04
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Mastocytosis
Mastocytosis, Systemic
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents