Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027664
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-12-07
Brief Title:
Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
Status:
UNKNOWN
Status Verified Date:
2002-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Thalidomide may stop the growth of cancer by stopping blood flow to the tumor It is not yet known if interferon alfa is more effective with or without thalidomide in treating metastatic kidney cancer
PURPOSE Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide in treating patients who have metastatic kidney cancer
PURPOSE Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the safety of interferon alfa and thalidomide in patients with metastatic renal cell carcinoma
Compare the relative toxicity of interferon alfa with or without thalidomide in these patients
Assess the antiangiogenic effect of thalidomide by monitoring the angiogenesis-associated factors in these patients
Compare in a preliminary manner the efficacy of interferon alfa with or without thalidomide in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive interferon alfa subcutaneously 3 times a week and oral thalidomide once daily for 12 weeks
Arm II Patients receive interferon alfa only as in arm I Treatment in both arms repeats every 12 weeks in the absence of disease progression or unacceptable toxicity Patients in arm II who develop disease progression discontinue interferon alfa and receive thalidomide only as in arm I
Quality of life is assessed at baseline and then every 3 weeks during each study course
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study
Determine the safety of interferon alfa and thalidomide in patients with metastatic renal cell carcinoma
Compare the relative toxicity of interferon alfa with or without thalidomide in these patients
Assess the antiangiogenic effect of thalidomide by monitoring the angiogenesis-associated factors in these patients
Compare in a preliminary manner the efficacy of interferon alfa with or without thalidomide in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive interferon alfa subcutaneously 3 times a week and oral thalidomide once daily for 12 weeks
Arm II Patients receive interferon alfa only as in arm I Treatment in both arms repeats every 12 weeks in the absence of disease progression or unacceptable toxicity Patients in arm II who develop disease progression discontinue interferon alfa and receive thalidomide only as in arm I
Quality of life is assessed at baseline and then every 3 weeks during each study course
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20129 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069055 | REGISTRY | None | None |