Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416871
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2006-12-27
Brief Title:
Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma MRCC Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients PERCY DUO
Status:
COMPLETED
Status Verified Date:
2012-09
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 Biological therapies such as interleukin-2 and interferon may stimulate the immune system in different ways and stop tumor cells from growing It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer
PURPOSE This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer
PURPOSE This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa
Secondary
Compare progression-free survival of patients treated with these regimens
Compare response rates complete and partial in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized parallel-group multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction therapy comprising interleukin-2 IL-2 IV continuously over days 1-5 15-19 43-47 and 57-61 weeks 1 3 7 and 9 and interferon alfa IFN-α subcutaneously SC three times weekly in weeks 1-3 and 7-9 Patients then undergo restaging Patients achieving a complete response CR partial response PR or stable disease SD then receive maintenance therapy comprising IL-2 IV continuously over 5 days and IFN-α SC three times weekly in weeks 1 5 9 and 13
Arm II Patients receive induction therapy comprising IL-2 SC twice daily on days 1-5 8-12 15-19 and 22-26 weeks 1-4 Patients also receive IFN-α SC three times weekly in weeks 1-4 and 6-9 Patients then undergo restaging Patients achieving a CR PR or SD then receive maintenance therapy comprising IL-2 SC as in induction therapy and IFN-α SC three times weekly in weeks 1-4 and 8-11
Quality of life is assessed at baseline at the end of induction therapy and then at the end of maintenance therapy
After completion of treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 220 patients will be accrued for this study
Primary
Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa
Secondary
Compare progression-free survival of patients treated with these regimens
Compare response rates complete and partial in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized parallel-group multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction therapy comprising interleukin-2 IL-2 IV continuously over days 1-5 15-19 43-47 and 57-61 weeks 1 3 7 and 9 and interferon alfa IFN-α subcutaneously SC three times weekly in weeks 1-3 and 7-9 Patients then undergo restaging Patients achieving a complete response CR partial response PR or stable disease SD then receive maintenance therapy comprising IL-2 IV continuously over 5 days and IFN-α SC three times weekly in weeks 1 5 9 and 13
Arm II Patients receive induction therapy comprising IL-2 SC twice daily on days 1-5 8-12 15-19 and 22-26 weeks 1-4 Patients also receive IFN-α SC three times weekly in weeks 1-4 and 6-9 Patients then undergo restaging Patients achieving a CR PR or SD then receive maintenance therapy comprising IL-2 SC as in induction therapy and IFN-α SC three times weekly in weeks 1-4 and 8-11
Quality of life is assessed at baseline at the end of induction therapy and then at the end of maintenance therapy
After completion of treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 220 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 |
|---|---|---|---|
| CHIRON-LEONB-PERCY-DUO | None | None | None |
| LEONB-PERCY-DUO | None | None | None |
| LEONB-ET99-057 | None | None | None |
| EU-20604 | None | None | None |
| ROCHE-LEONB-PERCY-DUO | None | None | None |