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

Myelodysplastic Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195104
• Other study ID #: 0603-887
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 14, 2005
• Last updated: March 2, 2017
• Start date: September 17, 2003
• Est. completion date: June 20, 2006

Study information

• Verified date: March 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 20, 2006
• Est. primary completion date: March 17, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Arsenic Trioxide (Tricenox)

• Cytarabine

Locations

Country	Name	City	State
United States	Weill Medcial College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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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