Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS).

Secondary: To evaluate response duration, survival and side effects of the treatment.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cyclosporine; Cyclosporins; Darbepoetin alfa; Epoetin Alfa; Lenograstim; Prednisone

Criteria

Inclusion Criteria:

1. Patients with MDS andlow or intermediate 1. No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2). Prior cytokines, biologic therapies, targeted therapies, or single agent chemotherapy allowed. Procrit, G-CSF are allowed before therapy. Patients with blasts < 5% must have an indication for therapy, such as transfusion needs, symptomatic anemia or Hb < 11g/dl, platelets < 100 x 10 9/L, or granulocytes < 10 9/L.

2. Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded)

3. Signed informed consent

Exclusion Criteria:

1. Nursing and pregnant females are excluded. Women of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

2. Patients with active and uncontrolled infections.