Pilot study of recombinant human soluble tumor necrosis factor receptor (TNFR:Fc) in patients with low risk myelodysplastic syndrome.
In low risk myelodysplastic syndrome (MDS), increased apoptosis of marrow cells is a reproducible finding. Cytokines may drive this apoptosis. Several studies have demonstrated elevated levels of tumor necrosis factor-alpha (TNF-alpha) in MDS. Soluble tumor necrosis factor receptor (TNFR:Fc) can eliminate biologically active TNF in vivo. This data provided the rationale for a clinical trial of TNFR:Fc in low risk MDS. Eligibility was limited to cytopenic MDS patients with < 10% marrow blasts. Secondary MDS was an exclusion. The study design was to administer 25mg TNFR:Fc twice a week for 10 weeks. Toxicity did not exceed grade 1. No responses were observed in the 10 treated patients and one had disease progression. At this dosing schedule, TNFR:Fc is unlikely to ameliorate cytopenias in low risk MDS.
Rosenfeld
Craig
C
craig.rosenfeld@usoncology.com
Bedell
Cindi
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000627:therapeutic use / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D010198:Pancytopenia / Q000139:chemically induced / Q000188:drug therapy; D010349:Patient Compliance; D010865:Pilot Projects; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage* / Q000627:therapeutic use; D012307:Risk Factors; D012995:Solubility; D017211:Treatment Failure; D016896:Treatment Outcome
D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept