Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045279
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-09-06
Brief Title:
PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma
Determine the time to disease progression in patients treated with this drug
Determine the safety of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the effect of this drug on biological surrogates of antitumor activity basic fibroblast growth factor vascular endothelial growth factor and interleukin-6 serum levels in these patients
OUTLINE Patients receive PEG-interferon alfa-2b subcutaneously once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at 2 weeks and at 2 4 8 and 12 months after initiation of study therapy and then at completion of study therapy
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 15 months
Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma
Determine the time to disease progression in patients treated with this drug
Determine the safety of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the effect of this drug on biological surrogates of antitumor activity basic fibroblast growth factor vascular endothelial growth factor and interleukin-6 serum levels in these patients
OUTLINE Patients receive PEG-interferon alfa-2b subcutaneously once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at 2 weeks and at 2 4 8 and 12 months after initiation of study therapy and then at completion of study therapy
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 15 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000256464 | REGISTRY | None | None |
| NCI-G-02-2102 | Registry Identifier | PDQ Physician Data Query | None |