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The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.
Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Patients | Experimental | Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arsenic Trioxide (Tricenox) | Drug |
| ||
| Cytarabine |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML. | 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML | |
| To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities. | 4 weeks after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the CR and PR rates in patients with high-risk MDS and poor-prognosis AML treated with the combination of ATO and low-dose ara-C. | 4 weeks after the last study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Roboz, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medcial College of Cornell University | New York | New York | 10021 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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|
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |