Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027664
Recruitment Status : Unknown
Verified March 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: recombinant interferon alfa Drug: thalidomide Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Study Start Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety
  2. Toxicity
  3. Response rate
  4. Anti-angiogenic effect
  5. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic renal cell carcinoma
  • Measurable progressive disease, defined as non-irradiated marker lesions greater than 1 cm



  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 12 weeks


  • Neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT less than 5 times ULN


  • Creatinine clearance greater than 50 mL/min OR
  • Edetic acid clearance greater than 40 mL/min


  • No unstable angina or myocardial infarction within the past 6 months


  • No other prior invasive malignancy except cervical intraepithelial neoplasia or nonmelanomatous skin cancer
  • No chronic neurological disease causing peripheral neuropathy
  • No diabetes mellitus
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use at least one highly effective method and at least one additional effective method of contraception for female patients and barrier contraception for male patients for at least 2 weeks before and during study


Biologic therapy:

  • No prior interferon alfa for metastatic renal cell carcinoma


  • No prior systemic chemotherapy for metastatic renal cell carcinoma
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • No concurrent corticosteroids


  • See Disease Characteristics
  • Concurrent local radiotherapy for symptomatic secondary sites of disease allowed if these sites are not being used as markers of disease response


  • Not specified


  • No other prior systemic treatment for metastatic renal cell carcinoma
  • No concurrent chronic medication known to cause peripheral neuropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027664

United Kingdom
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
Sponsors and Collaborators
Cancer Research UK
Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust Identifier: NCT00027664     History of Changes
Other Study ID Numbers: ICRF-C00.204
CDR0000069055 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: March 2002

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors