A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00251511|
Recruitment Status : Terminated (Sponsor terminated trial)
First Posted : November 10, 2005
Last Update Posted : May 11, 2012
This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS).
Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: Arsenic Trioxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||May 2007|
- Primary Study Endpoint:
- Determine the response rate (by IWG criteria) of patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS) to biweekly Trisenox plus daily Thalomid
- Secondary Study Endpoint(s):
- Determine the toxicities associated with a biweekly Trisenox plus daily Thalomid regimen, the event-free survival, and the overall survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251511
|United States, Texas|
|Houston, Texas, United States, 77042|
|Principal Investigator:||Ralph Boccia, MD||Veeda Oncology|