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Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-Risk Myelodysplastic Syndrome and Poor-Prognosis Acute Myelogenous Leukemia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-Risk Myelodysplastic Syndrome and Poor-Prognosis Acute Myelogenous Leukemia


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).


Inclusion Criteria:



- Histologic diagnosis of high-risk MDS (IPSS int-2).

- No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy
with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).

Exclusion Criteria:

- Pregnant or lactating women.

- Absolute QT interval >460 msec in the presence of serum potassium and magnesium
values within the normal range.

- Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or
investigational agents.

- Uncontrolled or severe cardiovascular or pulmonary disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Gail Roboz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

0603-887

NCT ID:

NCT00195104

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Weill Medcial College of Cornell UniversityNew York, New York  10021