Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059813
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2003-05-06
Brief Title:
Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of G3139 Genasense Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell kidney cancer Interferon alfa may interfere with the growth of tumor cells Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the objective response rate of metastatic renal cancer to the combination of G3139 plus α-Interferon α-IFN
SECONDARY OBJECTIVES
I To further assess the clinical toxicity of this combination II To evaluate the impact of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor cells and lymphocytes
III To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and schedule
IV To evaluate the potential toxicity of this combination on cells of the immune system
OUTLINE This is a multicenter study
Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4 6 8 10 and 12 of course 1 and on days 1 3 5 8 10 and 12 of all subsequent courses Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR receive an additional 2 courses past CR
Patients are followed for survival
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 20-24 months
I To estimate the objective response rate of metastatic renal cancer to the combination of G3139 plus α-Interferon α-IFN
SECONDARY OBJECTIVES
I To further assess the clinical toxicity of this combination II To evaluate the impact of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor cells and lymphocytes
III To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and schedule
IV To evaluate the potential toxicity of this combination on cells of the immune system
OUTLINE This is a multicenter study
Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4 6 8 10 and 12 of course 1 and on days 1 3 5 8 10 and 12 of all subsequent courses Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR receive an additional 2 courses past CR
Patients are followed for survival
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 20-24 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 |
|---|---|---|---|
| N01CM17101 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17101 |
| NCI-2012-02828 | REGISTRY | None | None |
| PHII-42 | OTHER | None | None |
| 5828 | OTHER | None | None |