Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied.

Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

1. Patients with low- or intermediate-1-risk MDS according to the International Prognostic Scoring System (IPSS) classification

2. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UT MD Anderson Cancer Center.

3. Age >/= 18 years old.

4. Prior therapy with growth factor support, lenalidomide, or other investigational agents is allowed.

5. Previously untreated patients are eligible for this study.

Exclusion Criteria:

1. Any previous adverse reaction (>/= Common Terminology Criteria for Adverse Events (CTCAE) grade 2) to GM-CSF.

2. Prior treatment with azacytidine or decitabine.

3. Unresolved diarrhea >/= CTCAE grade 2.