Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
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.
Biological: recombinant interferon alfa
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study|
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Anti-angiogenic effect [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||February 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027664
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Study Chair:||Adrian L. Harris, MD||Oxford University Hospitals NHS Trust|