This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an investigator-initiated study from the Case Comprehensive Cancer Center (UHC Ireland Cancer Center and the CCF Taussig Cancer Center). Completed preclinical studies and the preliminary clinical data suggest the fibroblast growth factor (FGF) mechanism as a potentially clinically important resistance mechanism in solid tumors including renal cell carcinoma (RCC), and that using low dose suramin as a chemosensitizer may offer therapeutic benefits. The hypothesis for this study is that the combination of suramin and weekly 5-Fluorouracil (5-FU) will be active and well tolerated in RCC patients. The primary objective of the Phase I portion of this trial is to determine the dose of weekly suramin, in combination with weekly 5-FU, that would result in 10-50 micro molar plasma concentrations from 4.5-48 hours after the start of suramin administration, in RCC patients. The primary objective of the Phase II portion of the trial is to determine the objective response rate in patients with metastatic RCC treated with the above treatment schedule. For both portions of the trial, a standard open label design will be used. Patients will receive a weekly intravenous infusion of suramin over 30 minutes followed by an IV bolus injection of 5-FU. The administration of 5-FU will be initiated 4.5 hours following initiation of suramin infusion, every week for 6 weeks in an 8-week cycle. The optimal dose of suramin will be determined in Phase I and this target dosage will be used in Phase II. Subjects will receive infusions of the study agent and have pharmacokinetics samples drawn at the GCRC for some (but not all) of their study visits. A total of 24 subjects will be enrolled at all centers; 6 subjects are expected at this site.
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