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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445900 |
RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia.
PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders |
Drug: cyclophosphamide Drug: prednisone Drug: thalidomide Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM) |
Estimated Enrollment: | 22 |
Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral thalidomide, oral prednisone, and oral cyclophosphamide (TPC) once daily on days 1-28. Treatment repeats every 28 days for 3 courses. After 3 courses (3 months) of treatment, patients who respond to TPC therapy may receive oral thalidomide alone once daily for up to 3 months in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow aspirate and biopsy prior to study entry, 6 months after starting therapy, and then every 6 months for up to 3 years.
Samples are analyzed by microvessel density/angiogenesis studies (i.e., CD34 immunohistochemical and vascular endothelium-specific staining) to determine the effect of therapy on markers of bone marrow angiogenesis.
After completion of study therapy, patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes:
Must have 1 of the following MMM-related conditions:
Anemia, defined as hemoglobin < 10 g/dL
No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following:
PATIENT CHARACTERISTICS:
No uncontrolled infection, including tuberculosis
No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000530973, MAYO-MC028A, MAYO-IRB-1360-03 |
Study First Received: | March 7, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00445900 History of Changes |
Health Authority: | United States: Federal Government |
chronic idiopathic myelofibrosis essential thrombocythemia polycythemia vera secondary myelofibrosis |
Anti-Inflammatory Agents Polycythemia Prednisone Thalidomide Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Anti-Bacterial Agents Metaplasia Chronic Myeloproliferative Disorders Thrombocytosis Neoplasm Metastasis Thrombocythemia, Hemorrhagic |
Hemorrhagic Thrombocythemia Alkylating Agents Polycythemia Vera Myelofibrosis Antineoplastic Agents, Hormonal Hematologic Diseases Myeloproliferative Disorders Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids Myeloid Metaplasia Lymphatic Diseases Essential Thrombocytosis Antineoplastic Agents, Alkylating Bone Marrow Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Prednisone Thalidomide Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Anti-Bacterial Agents Pathologic Processes Metaplasia Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Myelofibrosis Antineoplastic Agents, Hormonal Hematologic Diseases Growth Substances Myeloproliferative Disorders Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Myeloid Metaplasia Lymphatic Diseases Myeloablative Agonists |