Clinical Trials Directory

Trials / Completed

CompletedNCT00769288

FAU in Treating Patients With Advanced Solid Tumors or Lymphoma

A Phase I Study of Intravenously Administered FAU (1-(2'-Deoxy-2'-Fluoro-B-D-arabinofuranosyl) Uracil, NSC#678515) in Patients With Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. This phase I trial is studying the side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUG2'-F-ara-deoxyuridineGiven IV
OTHERpositron emission tomographyCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies
OTHERpharmacogenomic studiesCorrelative studies

Timeline

Start date
2009-07-01
Primary completion
2013-12-01
First posted
2008-10-09
Last updated
2014-01-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00769288. Inclusion in this directory is not an endorsement.