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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 Procedure: biopsy Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
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: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00445900 |
Health Authority: | United States: Federal Government |
chronic idiopathic myelofibrosis essential thrombocythemia polycythemia vera secondary myelofibrosis |
Essential thrombocytosis Polycythemia Polycythemia Vera Prednisone Myelofibrosis Thalidomide Hematologic Diseases Myeloproliferative Disorders Cyclophosphamide Polycythemia vera |
Myeloid Metaplasia Myelofibrosis-osteosclerosis Lymphatic Diseases Hemorrhagic thrombocythemia Metaplasia Chronic Myeloproliferative Disorders Neoplasm Metastasis Thrombocytosis Thrombocythemia, Hemorrhagic Bone Marrow Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |
Alkylating Agents Antineoplastic Agents, Hormonal Growth Substances Immunosuppressive Agents Glucocorticoids Angiogenesis Inhibitors Pharmacologic Actions Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Splenic Diseases Leprostatic Agents |