Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003542
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Interferon Alfa in Treating Patients With Advanced Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A RO 25-8310 in Previously Untreated Patients With Locally Advanced or Metastatic 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 Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase III trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer
PURPOSE Phase III trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of pegylated-interferon alfa-2a in patients with advanced or metastatic renal cell carcinoma II Evaluate the safety profile of the MTD in this patient population III Determine the objective response rate time to response duration of response time to progression and survival rate in this patient population
OUTLINE This is a dose escalation open label multicenter study Patients receive pegylated-interferon alfa-2a PEG-IFN subcutaneously once a week for 24 weeks Dose escalation of PEG-IFN continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity After the MTD of PEG-IFN is determined additional patients are treated at this dose level These patients may continue treatment after the first 24 weeks for up to 1 year in the absence of disease progression Patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 46-58 patients will be accrued for this study within 9 months
OUTLINE This is a dose escalation open label multicenter study Patients receive pegylated-interferon alfa-2a PEG-IFN subcutaneously once a week for 24 weeks Dose escalation of PEG-IFN continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity After the MTD of PEG-IFN is determined additional patients are treated at this dose level These patients may continue treatment after the first 24 weeks for up to 1 year in the absence of disease progression Patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 46-58 patients will be accrued for this study within 9 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 |
|---|---|---|---|
| NCI-G98-1475 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066596 | REGISTRY | None | None |
| ROCHE-NO15753C | None | None | None |
| UCLA-9903045 | None | None | None |