Arsenic Trioxide in Combination With Cytarabine in Patients With High-Risk MDS and Poor-Prognosis AML
This study has been completed.
Sponsor:
Weill Medical College of Cornell University
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195104
First received: September 14, 2005
Last updated: October 2, 2007
Last verified: October 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: Arsenic Trioxide (Tricenox) Drug: Cytarabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- 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.
- To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2003 |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195104
Locations
| United States, New York | |
| Weill Medcial College of Cornell University | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Gail Roboz, M.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00195104 History of Changes |
| Other Study ID Numbers: | 0603-887 |
| Study First Received: | September 14, 2005 |
| Last Updated: | October 2, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Weill Medical College of Cornell University:
|
Myelodysplastic Syndrome |
Additional relevant MeSH terms:
|
Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Leukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Arsenic trioxide |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013