Ignite Creation Date:
2024-05-05 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00769288
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2008-10-08
Brief Title:
FAU in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Intravenously Administered FAU 1-2-Deoxy-2-Fluoro-B-D-arabinofuranosyl Uracil NSC678515 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00248 | REGISTRY | None | None |
| CDR0000615651 | None | None | None |
| WSU2007-005 | None | None | None |
| WSU-2007-005 | OTHER | None | None |
| 7916 | OTHER | None | None |
| P30CA022453 | NIH | None | None |
| U01CA062487 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062487 |