Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002737
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A RANDOMIZED PHASE II TRIAL OF INTERFERON ALPHA-2A WITH AND WITHOUT 13-CIS RETINOIC ACID IN PATIENTS WITH PROGRESSIVE MEASURABLE METASTATIC RENAL CELL CARCINOMA Amendment Protocol Extension to a Randomized Phase III Trial
Status:
COMPLETED
Status Verified Date:
2012-07
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 the cancer cells and slow the growth of kidney cancer Isotretinoin may help kidney cancer cells develop into normal cells It is not yet known whether interferon alfa plus isotretinoin is more effective than interferon alfa alone for kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without isotretinoin in treating patients who have metastatic kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without isotretinoin in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES I Assess the response rate and response duration of interferon alfa with vs without isotretinoin in patients with bidimensionally measurable progressive metastases from renal cell cancer II Assess the toxic effects of these regimens in this patients population III Determine the overall survival of this patient population treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two treatment arms Arm I Patients receive interferon alfa subcutaneously daily Arm II Patients receive interferon alfa as in arm I plus oral isotretinoin daily Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 296 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to one of two treatment arms Arm I Patients receive interferon alfa subcutaneously daily Arm II Patients receive interferon alfa as in arm I plus oral isotretinoin daily Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 296 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 |
|---|---|---|---|
| EORTC-30951 | None | None | None |