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Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

NCT00225992 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-10-11

No results posted yet for this study

Summary

In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.

Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.

Conditions

  • Myelodysplastic Syndrome (MDS)

Interventions

DRUG

Arsenic Trioxide

Sponsors & Collaborators

  • Oncology Specialties, Alabama

    lead OTHER

Principal Investigators

  • John M. Waples, MD · Oncology Specialties, PC

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225992 on ClinicalTrials.gov