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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| 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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Triapine Plus Fludarabine 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) |
| Enrollment: | 37 |
| Study Start Date: | August 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
triapine, fludarabine
|
Drug: fludarabine phosphate
fludarabine d 1-5
Other Name: fludara
Drug: triapine
triapine d 1-5
Other Name: triapine
Genetic: cytogenetic analysis
bone marrow testing
Genetic: gene expression analysis
bone marrow testing
Genetic: mutation analysis
bone marrow testing
Other: laboratory biomarker analysis
bone marrow testing
Procedure: biopsy
bone marrow testing
|
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 | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Judith E. Karp, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00381550 History of Changes |
| Other Study ID Numbers: | J0638 CDR0000499828, U01CA070095, P30CA006973, JHOC-J0638, NCI-7704 |
| Study First Received: | September 26, 2006 |
| Last Updated: | August 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Bone Marrow Diseases Hematologic Diseases Pathologic Processes Myelodysplastic-Myeloproliferative Diseases |
Fludarabine monophosphate Vidarabine Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents |