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PEG-Interferon Alfa-2b, Sargramostim, and 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: NCT00090870
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : April 30, 2012
Information provided by:
Medical University of South Carolina

Brief Summary:

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: PEG-interferon alfa-2b Biological: sargramostim Drug: thalidomide Phase 2

Detailed Description:



  • Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.


  • Determine duration of response in patients treated with this regimen.
  • Determine the tolerance to and toxicity of this regimen in these patients.
  • Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
Study Start Date : April 2002
Primary Completion Date : March 2010
Study Completion Date : March 2010

Primary Outcome Measures :
  1. Response

Secondary Outcome Measures :
  1. Duration of response
  2. Tolerability
  3. Toxicity
  4. Median and progression-free survival

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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 renal cell carcinoma

    • Metastatic disease
  • Measurable disease

    • Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

      • Histologic confirmation required if measurable disease is confined to a solitary lesion
    • The following are not considered measurable disease:

      • Bone disease only
      • Pleural or peritoneal metastases
      • CNS lesions
      • Irradiated lesions unless disease progression was documented after prior radiotherapy



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 mg/dL
  • No decompensated liver disease


  • Creatinine ≤ 2.0 mg/dL


  • No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system
  • No history of autoimmune disease
  • No autoimmune hepatitis
  • No immunosuppressed transplantation recipients


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation
  • No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range
  • No severe psychiatric condition or disorder, including suicidal ideation or attempt
  • No other active malignancy except nonmelanoma skin cancer


Biologic therapy

  • No prior immunotherapy


  • Not specified

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy


  • Not specified

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): NCT00090870

United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina Identifier: NCT00090870     History of Changes
Other Study ID Numbers: CDR0000378049
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Medical University of South Carolina:
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
Peginterferon alfa-2b
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