PR104 and G-CSF in Treating Patients With Solid Tumors

OBJECTIVES: Primary * Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors. Secondary * Characterize the safety of this regimen in these patients. * Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite. * Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging. * Assess for antitumor toxicity in these patients. * Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia. OUTLINE: This is a multicenter, dose-escalation study of PR-104. Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to assess tumor hypoxia. Patients undergo blood sample collection periodically during course 1. Samples are analyzed for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia. After completion of study treatment, patients are followed at 30 days.