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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00381550 |
Purpose
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 |
|---|---|---|
|
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: | 42 |
| 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 42 patients will be accrued for this study.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Judith E. Karp ) |
| Study ID Numbers: | CDR0000499828, JHOC-J0638, NCI-7704 |
| Study First Received: | September 26, 2006 |
| Last Updated: | December 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00381550 History of Changes |
| 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 |
|
Antimetabolites Anti-Infective Agents Blast Crisis Vidarabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Neoplastic Processes Pathologic Processes Therapeutic Uses Neoplasms by Histologic Type Disease |
Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Leukemia, Myeloid Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Leukemia, Myelomonocytic, Acute Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases Cell Transformation, Neoplastic |