Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274781
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2006-01-10
Brief Title:
Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Phase II Trial of Combination Therapy With Arsenic Trioxide Trisenox and Gemtuzumab Ozogamicin Mylotarg for the Treatment of Adult Patients With Advanced Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as arsenic trioxide and gemtuzumab ozogamicin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve complete and partial remissions in patients with advanced myelodysplastic syndromes
Secondary
Determine the efficacy of this regimen in terms of 50 decrease in Red Blood Cell RBC transfusion requirements and change in hemoglobin concentration from baseline in patients treated with this regimen
Determine the platelet neutrophil bone marrow and cytogenic response in patients treated with this regimen
Determine the response duration in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a multicenter open-label study
Patients receive arsenic trioxide IV over 1 hour once daily on days 1-5 in week 1 and then twice weekly in weeks 2-12 They also receive gemtuzumab ozogamicin IV over 2 hours on day 8 Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 12 weeks during study treatment and then 4 weeks after the completion of study treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve complete and partial remissions in patients with advanced myelodysplastic syndromes
Secondary
Determine the efficacy of this regimen in terms of 50 decrease in Red Blood Cell RBC transfusion requirements and change in hemoglobin concentration from baseline in patients treated with this regimen
Determine the platelet neutrophil bone marrow and cytogenic response in patients treated with this regimen
Determine the response duration in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a multicenter open-label study
Patients receive arsenic trioxide IV over 1 hour once daily on days 1-5 in week 1 and then twice weekly in weeks 2-12 They also receive gemtuzumab ozogamicin IV over 2 hours on day 8 Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 12 weeks during study treatment and then 4 weeks after the completion of study treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCF-6818 | OTHER | Cleveland Clinic IRB | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |