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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: | NCT00437086 |
RATIONALE: Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
PURPOSE: This clinical trial is studying the side effects and how well bortezomib works in treating patients with advanced myeloproliferative disorders.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Leukemia |
Drug: bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Prospective Open-Label Pilot Trial of PS-341 (Bortezomib; VELCADE) for the Therapy of Symptomatic Advanced Myeloproliferative Disorders |
Estimated Enrollment: | 30 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, open-label, pilot, multicenter study. Patients are stratified according to disease (systemic mast cell disease vs chronic myelomonocytic leukemia vs myelofibrosis with myeloid metaplasia).
Patients receive bortezomib IV weekly for 4 weeks. Treatment repeats every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (complete remission, partial remission, or minimal remission) after 2 courses may receive an additional 6 courses of therapy. Patients who achieve stable disease with acceptable toxicities after 2 courses receive bortezomib IV at a higher dose twice weekly for 2 weeks. Treatment with a higher dose of bortezomib repeats every 3 weeks for up to 6 courses.
Patients who are responders undergo bone marrow aspirate or biopsy and peripheral blood collection for evaluation of bone marrow cellularity, tryptase-positive mast cells, reticulin fibrosis, osteosclerosis, and angiogenesis by fluorescent in situ hybridization (FISH), immunohistochemistry, and other immunological laboratory methods.
After completion of study therapy, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 30 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 advanced myeloproliferative disorder, including 1 of the following subtypes:
Myelofibrosis with myeloid metaplasia defined by the following criteria:
Evaluable or symptomatic disease as evidenced by ≥ 1 of the following:
Chronic myelomonocytic leukemia (CMML) defined by the following criteria:
Symptomatic disease as evidenced by ≥ 1 of the following:
Systemic mast cell disease defined by the following criteria:
PATIENT CHARACTERISTICS:
No evidence of acute ischemia or active conduction system abnormality by ECG
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Ruben A. Mesa, MD | Mayo Clinic |
Investigator: | Srdan Verstovsek, MD | M.D. Anderson Cancer Center |
Investigator: | Ayalew Tefferi, MD | Mayo Clinic |
Investigator: | Mark R. Litzow, MD | Mayo Clinic |
Investigator: | Alexandra P. Wolanskyj, MD | Mayo Clinic |
Investigator: | Michelle A. Elliott, MD | Mayo Clinic |
Investigator: | William J. Hogan, MD | Mayo Clinic |
Investigator: | David P. Steensma, MD | Mayo Clinic |
Investigator: | Animesh D. Pardanani, MD | Mayo Clinic |
Investigator: | Scott H. Kaufmann, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000529906, MAYO-MC0486, MAYO-IRB-695-05 |
Study First Received: | February 15, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00437086 |
Health Authority: | United States: Federal Government |
chronic myelomonocytic leukemia chronic idiopathic myelofibrosis |
Myeloid Metaplasia Leukemia Myelofibrosis Chronic myelomonocytic leukemia Hematologic Diseases |
Leukemia, Myelomonocytic, Chronic Bortezomib Chronic Myeloproliferative Disorders Myeloproliferative Disorders Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |