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Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable 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: NCT00005966
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 5, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: recombinant interferon alfa Drug: thalidomide Phase 3

Detailed Description:


  • Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide.
  • Compare the safety of these 2 regimens in these patients.
  • Compare the quality of life of patients treated with these 2 regimens.
  • Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year), and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on day 1.
  • Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past CR.

Quality of life is assessed prior to randomization and then every 4 weeks through week 24.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
Study Start Date : October 2000
Actual Primary Completion Date : March 2006

Information from the National Library of Medicine

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


  • Histologically proven previously untreated metastatic or unresectable renal cell carcinoma

    • Retroperitoneal lymph nodes that are unresectable or those that are not resected at the investigator's discretion are considered metastatic disease
    • Prior nephrectomy allowed provided there is evidence of unresponsive metastatic disease after surgery or within one month prior to study enrollment
  • Bidimensionally measurable disease

    • Measurable disease must be outside any prior radiotherapy port
  • No history of brain metastases unless surgically resected or treated with gamma knife radiotherapy and currently without radiologic evidence of CNS disease



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction within the past 6 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception (1 highly active method and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled diabetes or any other concurrent illnesses that would increase risk
  • No history of peripheral neuropathy
  • No severe depression


Biologic therapy:

  • No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy, or vaccine therapy for renal cell carcinoma
  • No prior antiangiogenesis therapy for renal cell carcinoma
  • Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)


  • No prior chemotherapy for renal cell carcinoma
  • Chemotherapy for prior malignancy allowed

Endocrine therapy:

  • No prior hormonal therapy for renal cell carcinoma


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered


  • See Disease Characteristics


  • More than 7 days since prior IV antibiotics for infection

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): NCT00005966

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United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
United States, Nebraska
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Michael S. Gordon, MD Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Publications of Results:
Gordon MS, Manola J, Fairclough D, et al.: Low dose interferon-α2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS). A phase III study of the Eastern Cooperative Oncology Group (E2898). [Abstract] J Clin Oncol 22 (Suppl 14): A-4516, 386s, 2004.

Layout table for additonal information Identifier: NCT00005966     History of Changes
Other Study ID Numbers: CDR0000067949
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: September 2002

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

Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Interferon alpha-2
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