Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005045
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-04-06
Brief Title:
Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Carboxyamidotriazole CAI NSC 609974 in Patients With Advanced Renal Cell Carcinoma Refractory to Immunotherapy
Status:
COMPLETED
Status Verified Date:
2005-12
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 Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy
PURPOSE Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy
Detailed Description:
OBJECTIVES I Determine the disease free progression at 6 months in patients with locally recurrent or metastatic renal cell cancer refractory to immunotherapy treated with carboxyamidotriazole II Evaluate the progression free survival rate and response rate in these patients on this regimen III Evaluate the toxic effect of this regimen on these patients
OUTLINE Patients receive oral carboxyamidotriazole daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease may discontinue therapy after 6 courses Patients are followed every 3 months for 2 years every 6 months for 3 years and every 12 months thereafter until death
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 20 months
OUTLINE Patients receive oral carboxyamidotriazole daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease may discontinue therapy after 6 courses Patients are followed every 3 months for 2 years every 6 months for 3 years and every 12 months thereafter until death
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 20 months
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 |
|---|---|---|---|
| ECOG-4896 | None | None | None |