Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of FAU in patients with advanced solid tumors or lymphoma. II. To determine the dose-limiting toxicity and maximum tolerated dose (MTD) of FAU in these patients. SECONDARY OBJECTIVES: I. To observe the clinical response in patients treated with FAU. II. To characterize the pharmacokinetics of FAU in these patients. III. To explore whether an association exists between pre-treatment 18F-FAU PET standardized uptake value levels and time to tumor progression after treatment with unlabeled FAU. IV. To estimate the protein levels of thymidylate synthase (TS) in archival tumor tissue samples and to compare them with thymidine kinase (TK) and TS protein levels and TK and TS mRNA levels in fresh tumor tissue samples from patients treated at the MTD. V. To explore the relationship between genetic polymorphisms of TS and tumor 18F-FAU uptake. OUTLINE: This is a multicenter study. Patients receive FAU IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
