Viewing Study NCT00005642



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Study NCT ID: NCT00005642
Status: COMPLETED
Last Update Posted: 2010-06-11
First Post: 2000-05-02

Brief Title: SU5416 in Treating Patients With Advanced Solid Tumors
Sponsor: Case Comprehensive Cancer Center
Organization: Case Comprehensive Cancer Center

Study Overview

Official Title: A Phase I Pharmacodynamic Trial of SU5416 NSC 696819
Status: COMPLETED
Status Verified Date: 2010-06
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: RATIONALE SU5416 may stop the growth of cancer by stopping blood flow to the tumor

PURPOSE Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors
Detailed Description: OBJECTIVES I Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors II Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response stabilization of disease or progression-free survival in this patient population III Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population IV Determine prognostic and surrogate serologic markers in these patients treated with this regimen V Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors basic fibroblast growth factor and vascular endothelial cell growth factor are prognostic in predicting patient response to this regimen VI Determine if elevated plasma levels of endothelial cell specific proteins reflective of SU5416-induced endothelial damage andor apoptosis are useful surrogate markers in assessing response to this treatment regimen in these patients

OUTLINE This is a dose-deescalation study Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose MTID is determined The MTID is defined as the dose at which patients experience no greater than grade 1 toxicity Patients are followed every 3 months

PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study

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-T99-0095 US NIH GrantContract None httpsreporternihgovquickSearchP30CA043703
U01CA062502 NIH None None
P30CA043703 NIH None None
CWRU-2Y99 None None None