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Completed

NCT Number: NCT00195104

Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Weill Medcial College of Cornell University

New York, 10021, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arsenic Trioxide (Tricenox)

Drug

Cytarabine

Drug

Primary outcomes

  1. 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.

    Time frame: 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML

  2. To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.

    Time frame: 4 weeks after the last study treatment

Secondary outcomes

  1. 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.

    Time frame: 4 weeks after the last study treatment

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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