Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion

• MDS classified by hematopathology review as WHO categories refractory anemia (RA) or refractory cytopenia with multi-lineage dysplasia (RCMD) or refractory anemia with ring sideroblasts (RARS) or refractory anemia with excess blasts (RAEB1 or RAEB2) or chronic myelo-monocytic leukemia (CMML1 or CMML2)

• Symptomatic anemia OR thrombocytopenia with a platelet count of < 100 x 10^9/L OR transfusion dependence for red-cells OR transfusion dependence for platelets OR absolute neutrophil count < 1 x 10^9/L

Exclusion

• MDS of the WHO sub-types RA or RCMD with sole 5q- abnormality on cytogenetics unless failed lenalidomide (Revlimid) therapy

• Previous treatment with decitabine

• Untreated erythropoietin deficiency defined as an erythropoietin level of < 200 IU/L and erythropoietin replacement therapy for < 8 weeks (erythropoietin deficiency until corrected)

• Uncontrolled infection

• Severe sepsis or septic shock

• Current pregnancy or breast feeding

• The patient is of childbearing age, and is unwilling to use contraception and has not had a tubal ligation, hysterectomy, or vasectomy , or their partner is also unwilling to use an acceptable method of contraception as determined by the investigator

• Not able to give informed consent

• Altered mental status or seizure disorder

• ALT > 300 IU; or albumin < 2.0 mg/dL

• Creatinine > 2.5 mg/dl and creatinine clearance < 60ml/min

• B12, folate, or iron deficient, until corrected

• NYHA class III/IV status

• ECOG performance status > 2

• HIV positive or history of seropositivity for HIV

• Transformation to acute leukemia ( >= 20% myelo-blasts in marrow aspirate)

• Any experimental agents other than the study drug decitabine