Status:
TERMINATED
Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
CTI BioPharma
Celgene Corporation
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of azacitidine when given in combination with arsenic trioxide in patients with myelodysplastic syndromes (MDS). (Phase I) * Determine the ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of MDS by standard criteria. Patients within each of the FAB diagnostic groups of RA, RARS, RAEB, RAEBt, and CMML are eligible. For patients with lower-risk MDS only: documented red blood cell dependence, defined as the inability to maintain a hematocrit of \> 25% without transfusion support.
- Adequate marrow iron stores
- In patients with serum erythropoietin less than 200 IU/mL at screening, failure to have responded to a 2 to 3 month trial of recombinant erythropoietin
- Serum creatinine or serum bilirubin \< 1.5 times the upper limit of normal; higher levels are acceptable if ALT levels \< 2 x upper limits of normal
- Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine/treatment.
- Women of childbearing potential should be advised to avoid becoming pregnant and should be advised to not father a child while receiving treatment with azacitidine
- Age \> 18 years
Exclusion
- Treatment with growth factors within the 30 days before first treatment with ATO/Azacitidine, except that patients with serum erythropoietin \< 200 IU/mL who failed to respond to a trial with EPO are not excluded regardless of the time since last EPO
- Treatment with cytotoxic or experimental agents within 30 days before first treatment with ATO/Azacitidine
- Absolute QT interval \> 460 msec in the presence of adequate serum potassium and magnesium values
- Active serious infections that are not controlled by antibiotics
- Pregnant or lactating women
- Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- NYHA Class III or IV heart failure
- Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00234000
Start Date
February 1 2007
Last Update
July 31 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781