Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293501
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2006-02-16
Brief Title:
Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Sponsor:
University of Vermont
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Tinzaparin Innohep a Low Molecular Weight Heparin LMWH for Treatment of Advanced Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor
PURPOSE This phase III trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery
PURPOSE This phase III trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the effect of tinzaparin sodium on fibrin formation prothrombin fragment F12 thrombin generation thrombin-antithrombin complexes and fibrinolysis D-Dimer from baseline to 2 weeks and at nadir or disease progression in patients with unresectable metastatic renal cell carcinoma RCC
Secondary
Determine the effect of tinzaparin sodium treatment on circulating angiogenesis markers including vascular endothelial growth factor VEGF and basic fibroblast growth factor bFGF
Determine the proportion of patients developing venous thromboembolism and hemorrhage
Determine the tolerability of tinzaparin sodium treatment for up to 6 months in these patients
Establish the feasibility of undertaking a multicenter renal cell carcinoma trial with specialized coagulation test collection shipping and processing
Obtain more accurate and specific mean median and variability in biomarker data in advanced RCC patients treated with tinzaparin sodium for purposes of planning larger future trials
Estimate the progression-free survival at 4 months in patients treated with tinzaparin sodium
Correlate progression-free survival with changes in markers of coagulation activation or angiogenesis
Correlate the anticoagulant activity of tinzaparin sodium anti-Xa activity with change in coagulation markers angiogenesis markers and progression-free survival
OUTLINE This is an open-label pilot multicenter study
Patients receive a treatment dose of tinzaparin sodium subcutaneously SC once daily for 14 days followed by a prophylactic dose of tinzaparin sodium SC once daily for up to 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the effect of tinzaparin sodium on fibrin formation prothrombin fragment F12 thrombin generation thrombin-antithrombin complexes and fibrinolysis D-Dimer from baseline to 2 weeks and at nadir or disease progression in patients with unresectable metastatic renal cell carcinoma RCC
Secondary
Determine the effect of tinzaparin sodium treatment on circulating angiogenesis markers including vascular endothelial growth factor VEGF and basic fibroblast growth factor bFGF
Determine the proportion of patients developing venous thromboembolism and hemorrhage
Determine the tolerability of tinzaparin sodium treatment for up to 6 months in these patients
Establish the feasibility of undertaking a multicenter renal cell carcinoma trial with specialized coagulation test collection shipping and processing
Obtain more accurate and specific mean median and variability in biomarker data in advanced RCC patients treated with tinzaparin sodium for purposes of planning larger future trials
Estimate the progression-free survival at 4 months in patients treated with tinzaparin sodium
Correlate progression-free survival with changes in markers of coagulation activation or angiogenesis
Correlate the anticoagulant activity of tinzaparin sodium anti-Xa activity with change in coagulation markers angiogenesis markers and progression-free survival
OUTLINE This is an open-label pilot multicenter study
Patients receive a treatment dose of tinzaparin sodium subcutaneously SC once daily for 14 days followed by a prophylactic dose of tinzaparin sodium SC once daily for up to 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| VCC-05-040 | None | None | None |
| VCC-0403 | None | None | None |