Trial record 19 of 54 for:    "Mastocytosis"

Use of Tamoxifen in Systemic Mastocytosis

This study is currently recruiting participants.
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334996
First received: December 25, 2007
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Systemic Mastocytosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Systemic Mastocytosis With Tamoxifen

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Stability or improvement in biochemical markers of systemic mastocytosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 6
Study Start Date: February 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Joseph Butterfield M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01334996     History of Changes
Other Study ID Numbers: 2506-04
Study First Received: December 25, 2007
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014