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| Sponsored by: |
Cancer Research UK |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027664 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study |
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United Kingdom, England | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Peter J. Selby, MD, MA, FRCP 113-242-9883 | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Contact: Adrian L. Harris, MD 44-1865-226-184 | |
| United Kingdom, Scotland | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Contact: Paul A. Vasey, MD 44-141-3304-4006 pav1y@clinmed.gla.ac.uk | |
| Study Chair: | Adrian L. Harris, MD | Oxford Radcliffe Hospital |
More Information
| Study ID Numbers: | CDR0000069055, ICRF-C00.204, EU-20129 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027664 History of Changes |
| Health Authority: | Unspecified |
|
stage IV renal cell cancer |
|
Interferon-alpha Urinary Tract Neoplasm Interferon Type I, Recombinant Kidney Cancer Immunologic Factors Thalidomide Interferons Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Angiogenesis Inhibitors |
Antiviral Agents Carcinoma Anti-Bacterial Agents Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Interferon Type I, Recombinant Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Anti-Bacterial Agents Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Growth Inhibitors Kidney Diseases |
Angiogenesis Modulating Agents Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Renal Cell Adenocarcinoma Interferon Alfa-2a Leprostatic Agents |