Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291369
Status:
COMPLETED
Last Update Posted:
2006-02-16
First Post:
2006-02-13
Brief Title:
Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
PERCY QUATTRO Medroxyprogesterone Interferon Alpha-2a Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis
Status:
COMPLETED
Status Verified Date:
2006-02
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:
The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine treatments Interleukin-2 IL2 andor alpha interferon IFN for patients with intermediate chance of response in metastatic renal cell carcinoma
Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone MPA subcutaneous IFN subcutaneous IL2 or a combination of IFN and IL2
The primary objective of the study is overall survival secondary objectives are progression-free survival response rate toxicity and quality of life
Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone MPA subcutaneous IFN subcutaneous IL2 or a combination of IFN and IL2
The primary objective of the study is overall survival secondary objectives are progression-free survival response rate toxicity and quality of life
Detailed Description:
The PERCY Quattro trial has been designed to evaluate the survival benefit of Interleukin-2 IL2 andor alpha interferon IFN for patients with intermediate chance of response in metastatic renal cell carcinoma
The primary objective is overall survival and secondary objectives are progression-free survival response rate toxicity and quality of life assessed before and after induction treatment week 10
Patients above 18 years of age are eligible if they have histologically confirmed clearly progressive metastatic renal carcinoma more than one metastatic organ and good performance status Karnofsky score 80 or one metastatic organ with Karnofsky score 80 normal blood and liver functions with creatinine level 160 µmolL
Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone MPA subcutaneous IFN subcutaneous IL2 or a combination of IFN and IL2 The planned sample size is 456 patients 114 in each of the four arms MPA is given orally as 200 mg daily IFN is given subcutaneously as 9 million IU three times a week IL2 is given subcutaneously on a four-week schedule 9 million IU twice daily for five days followed by a two-day rest then on the following three weeks 9 million IU twice daily for two days then 9 million IU once daily on the following three days after a week of rest an identical 4-week cycle is administered IFN and IL2 combination is given using identical routes schedules and doses except for a reduction of IFN dose to 6 million IU per injection
The primary objective is overall survival and secondary objectives are progression-free survival response rate toxicity and quality of life assessed before and after induction treatment week 10
Patients above 18 years of age are eligible if they have histologically confirmed clearly progressive metastatic renal carcinoma more than one metastatic organ and good performance status Karnofsky score 80 or one metastatic organ with Karnofsky score 80 normal blood and liver functions with creatinine level 160 µmolL
Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone MPA subcutaneous IFN subcutaneous IL2 or a combination of IFN and IL2 The planned sample size is 456 patients 114 in each of the four arms MPA is given orally as 200 mg daily IFN is given subcutaneously as 9 million IU three times a week IL2 is given subcutaneously on a four-week schedule 9 million IU twice daily for five days followed by a two-day rest then on the following three weeks 9 million IU twice daily for two days then 9 million IU once daily on the following three days after a week of rest an identical 4-week cycle is administered IFN and IL2 combination is given using identical routes schedules and doses except for a reduction of IFN dose to 6 million IU per injection
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 |
|---|---|---|---|
| ET99-058 | None | None | None |