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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00381550 |
RATIONALE: Drugs used in chemotherapy, such as 3-AP and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 3-AP may help fludarabine work better by making cancer cells more sensitive to the drug. 3-AP and fludarabine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving 3-AP together with fludarabine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving 3-AP together with fludarabine works in treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic leukemia (CMML), or accelerated phase or blastic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia |
Drug: fludarabine phosphate Drug: triapine Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: mutation analysis Other: laboratory biomarker analysis Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Triapine (IND # 68338, NSC #663249, 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbone) Plus Fludarabine (NSC #312887, Fludarabine Monophosphate) in Adults With Aggressive Myeloproliferative Disorders (MPDs) Including Chronic Myelomonocytic Leukemia (CMML) and Chronic Myelogenous Leukemia in Accelerated Phase (CML-AP) or Blast Crisis (CML-BC) |
Estimated Enrollment: | 35 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow and/or peripheral blood collection at baseline and periodically during study treatment for molecular analysis of Janus kinase 2 (JAK2) mutations, GATA-1 mutations, and expression of the death-inducer-obliterator (Dido) genes on chromosome 20q.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 35 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:
Histopathologically confirmed diagnosis of 1 of the following:
Myeloproliferative disorders (MPDs) in aggressive phase or transformation, including the following:
Patients with aggressive phase MPD (PV, ET, or Ph- CML) must meet ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
No active uncontrolled infection
PRIOR CONCURRENT THERAPY:
At least 48 hours since prior noncytotoxic agents for peripheral blood leukemic cell count control, including but not limited to the following:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000499828, JHOC-J0638, NCI-7704 |
Study First Received: | September 26, 2006 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00381550 |
Health Authority: | Unspecified |
polycythemia vera essential thrombocythemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia Philadelphia chromosome negative chronic myelogenous leukemia |
chronic myelomonocytic leukemia relapsing chronic myelogenous leukemia chronic idiopathic myelofibrosis atypical chronic myeloid leukemia chronic eosinophilic leukemia |
Polycythemia Philadelphia Chromosome Blast Crisis Chronic myelogenous leukemia Chronic myelomonocytic leukemia Leukemia Hemorrhagic thrombocythemia Chronic Myeloproliferative Disorders Thrombocytosis Thrombocythemia, Hemorrhagic Aggression Polycythemia Vera Essential thrombocytosis Myelofibrosis Hematologic Diseases |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Fludarabine monophosphate Polycythemia vera Leukemia, Myeloid Myeloid Metaplasia Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases |
Antimetabolites Disease Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Cell Transformation, Neoplastic |