Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
NCT ID: NCT00569010
Last Updated: 2012-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2005-12-31
2009-10-31
Brief Summary
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Detailed Description
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If you are found to be eligible to take part in this study, you will be assigned to a treatment group. You will be randomly assigned (as in the toss of a coin) to one of the 4 treatment groups. The first 3 to 6 patients will be assigned to Group 1. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 2. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 3. If no serious side effects are experienced, the next 3 to 6 patients will be assigned to Group 4.
If you are in Group 1, you will receive low-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive low-dose ara-C as a continuous infusion by vein for 7 days.
If you are in Group 2, you will receive high-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive low-dose ara-C as a continuous infusion by vein for 7 days.
If you are in Group 3, you will receive low-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive high-dose ara-C as a continuous infusion by vein for 3 days (if you are 65 years of age or older) or for 4 days (if you are younger than 65 years of age).
If you are in Group 4, you will receive high-dose 5-azacytidine as an infusion by vein over 20 to 30 minutes every day for 7 days. You will also receive high-dose ara-C as a continuous infusion by vein for 3 days (if you are 65 years of age or older) or for 4 days (if you are younger than 65 years of age).
Each group's treatment will be repeated every 4 to 8 weeks (this is considered 1 cycle of treatment), depending on your blood counts and how well your bone marrow is recovering. You will receive at least 2 cycles of treatment. You will continue to receive treatment, unless your disease gets worse or if you experience intolerable side effects. If your disease gets worse or you experience intolerable side effects, you may be taken off this study.
This is an investigational study. 5-azacytidine has been approved by the FDA for the treatment of MDS. Ara-C has been approved by the FDA for the treatment of AML. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-Dose Ara-C + AZA-Level 0
Group 1 = Low-Dose Ara-C + Azacitidine-Level 0
Low-Dose Ara-C: 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days Azacitidine (AZA): 37.5 mg/m\^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
Azacitidine
Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Ara-C
Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)
Low-Dose Ara-C + AZA-Level 1
Group 2 = Low-Dose Ara-C + Azacitidine-Level 1
Low-Dose Ara-C: 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Azacitidine
Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Ara-C
Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)
High-Dose Ara-C + AZA-Level 0
Group 3 = High-Dose Ara-C + Azacitidine-Level 0 High-dose Ara-C: 1 g/m\^2 Daily CIV for 4 days (age\<65years) or 3 days (age\>=65years) AZA: 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days
Azacitidine
Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Ara-C
Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)
High-Dose Ara-C + AZA-Level 1
Group 4 = High-Dose Ara-C + Azacitidine-Level 1
High-dose Ara-C: 1 g/m\^2 Daily CIV for 4 days (age\<65years) or 3 days (age\>=65 years) AZA:Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Azacitidine
Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Ara-C
Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)
Interventions
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Azacitidine
Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days
Ara-C
Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with (1) refractory disease or (2) first relapse within 6 months of therapy or (3) 2nd or more of relapse of Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome MDS will be considered for the study.
3. Patients must have been off chemotherapy for 4 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
4. Age \>=18 years. Deoxyribonucleic acid (DNA) methylation plays a significant role in development, and the effects of azacitidine in children are not well described.
5. Patients must have normal organ as defined: Total bilirubin \<2 mg, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<2.5 x institutional upper limit of normal, Creatinine \<2 mg
6. Ability to understand and the willingness to sign a written informed consent document.
7. Women of child bearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
8. Women of child bearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacytidine.
9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion Criteria
2. Patients may not be receiving any other investigational agents for their leukemias.
3. Patients with active brain or meningeal disease should be excluded.
4. Known or suspected hypersensitivity to azacitidine or mannitol
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Pregnant women are excluded from this study because azacitidine is a Deoxyribonucleic acid (DNA) methyltransferase inhibitor which has teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jean-Pierre Issa, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M.D. Anderson's Website
Other Identifiers
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2005-0291
Identifier Type: -
Identifier Source: org_study_id