3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia - NCT00381550-21231(Clinical Trial 150666)
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Baltimore |
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State:
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MD |
| Zip Code: |
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21231 |
| Conditions: |
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Chronic Myeloproliferative Disorders - Leukemia |
| Purpose: |
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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.
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| Study summary: |
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OBJECTIVES:
- Determine the efficacy of 3-AP (Triapine®) followed by fludarabine phosphate in
patients with myeloproliferative disorders or chronic myelomonocytic leukemia in
aggressive phase or transformation or chronic myelogenous leukemia in accelerated phase
or blast crisis.
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on circulating leukemic cell
genetics in these patients.
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. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histopathologically confirmed diagnosis of 1 of the following:
- Myeloproliferative disorders (MPDs) in aggressive phase or transformation,
including the following:
- Polycythemia vera (PV)
- Essential thrombocythemia (ET)
- Myelofibrosis with myeloid metaplasia
- Hypereosinophilic syndrome
- Atypical (Philadelphia chromosome negative) chronic myelogenous leukemia
(Ph- CML)
- CML in accelerated phase or blast crisis
- Chronic myelomonocytic leukemia in aggressive phase (5-19% bone marrow blasts)
or transformation (> 20% bone marrow blasts)
- Patients with aggressive phase MPD (PV, ET, or Ph- CML) must meet ≥ 1 of the
following criteria:
- Marrow blasts > 5%
- Peripheral blood blasts plus progranulocytes > 10%
- New onset or increasing myelofibrosis
- New onset or > 25% increase in hepatomegaly or splenomegaly
- New onset constitutional symptoms (fever, weight loss, splenic pain, bone pain)
- Multilineage bone marrow failure
- Ineligible for established curative regimens, including stem cell transplantation
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- AST and ALT ≤ 2.5 times normal
- Bilirubin ≤ 2.0 mg/dL unless due to leukemia, Gilbert's syndrome, or hemolysis
- No chronic toxicity from prior chemotherapy > grade 1
- No active heart disease
- No myocardial infarction within the past 3 months
- No history of severe coronary artery disease
- No arrhythmias (other than atrial flutter or fibrillation) requiring medication
- No uncontrolled congestive heart failure
- No dyspnea at rest or with minimal exertion
- No severe pulmonary disease requiring supplemental oxygen
- No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- G6PD screening required for high-risk groups (i.e., patients of African, Asian,
or Mediterranean origin/ancestry)
- No active uncontrolled infection
- Infections under active treatment and controlled with antibiotics are allowed
- No chronic hepatitis
- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to 3-AP (Triapine®) and/or fludarabine phosphate
- No other life-threatening illness
- No history of mental deficits and/or psychiatric illness that would preclude study
compliance
PRIOR CONCURRENT THERAPY:
- No more than 4 prior induction regimens (3 cytotoxic chemotherapy regimens)
- At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin
C or nitrosoureas) and recovered
- At least 1 week since prior nonmyelosuppressive treatment
- At least 48 hours since prior noncytotoxic agents for peripheral blood leukemic cell
count control, including but not limited to the following:
- Hydroxyurea
- Imatinib mesylate
- Interferon
- Mercaptopurine
- Cyclophosphamide
- At least 2 weeks since prior and no concurrent radiotherapy to treat cancer
- At least 1 week since prior biologic therapy, including hematopoietic growth factors
(e.g., epoetin alfa, darbepoetin alfa, filgrastim [G-CSF], sargramostim [GM-CSF],
interleukin-3, or interleukin-11)
- No concurrent myeloid growth factors
- No other concurrent chemotherapy to treat cancer
- No concurrent immunotherapy to treat cancer |
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| Study is available at: |
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, MD 21231
United States
Primary Contact:
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce
Email: jhcccro@jhmi.edu
Phone: 410-955-8804 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
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