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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"


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia

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Trial Information

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.


Inclusion Criteria:



1. Patients must have histologically confirmed Acute Myeloid Leukemia (AML) or high risk
and previously treated Myelodysplastic Syndrome (MDS).

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:

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier,
unless there is evidence of rapidly progressive disease. Patients may have received
hydroxyurea prior to entering the study.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Remission

Outcome Description:

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.

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Jean-Pierre Issa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0291

NCT ID:

NCT00569010

Start Date:

December 2005

Completion Date:

October 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Acute Myelogenous Leukemia
  • AML
  • Myelodysplastic Syndrome
  • MDS
  • Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030