Randomized Phase I/II Study of 5-Azacytidine in Combination With Cytosine Arabinoside in Patients With Relapsed/Refractory Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome - "SPORE"
5-azacytidine is designed to "turn off" the growth of cancer cells. This may be increased by
ara-C, which is designed to kills leukemia cells by helping to stop the cells from dividing.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Remission
Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.
6 weeks
No
Jean-Pierre Issa, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2005-0291
NCT00569010
December 2005
October 2009
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |