PENTOXIFYLLINE AND CIPROFLOXACIN IN PATIENTS WITH MYELODYSPLASTIC SYNDROME - A PHASE-II TRIAL

Tumor necrosis factor (TNF) inhibits hematopoietic cell proliferation, The combination of pentoxifylline (PTX) and ciprofloxacin (Cipro) has been previously shown to reduce circulating serum levels of TNF. In t his Phase II trial 14 patients with advanced myelodysplastic syndrome were treated with PTX (2,000 mg/day) and Cipro (1,000 mg/day) in order to determine tolerability and effect on peripheral blood cell counts, progenitor cell responsiveness to cytokines and circulating serum lev els of interleukin-6 (IL6) and TNF. Toxicity attributed to PTX and Cip ro were limited to nausea in 4 patients, Peripheral blood cell counts, platelet transfusion requirements and red blood cell transfusion requ irements did not change during administration of PTX and Cipro (daily for 28 days). Marrow progenitor cells of patients entered into trial w ere less responsive to stimulation with cytokines in vitro at baseline and during the trial compared to normal volunteers. Eight patients ha d elevated IL6 levels before treatment with PTX and Cipro these levels did not change during therapy. Five patients had elevated TNF levels at baseline, There was a suggestion of decreased TNF levels during tre atment with PTX and Cipro (P = .09). In conclusion, PTX and Cipro was well tolerated but no evidence of efficacy was observed.