PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Information provided by:
Medical University of South Carolina Identifier:
First received: September 7, 2004
Last updated: April 26, 2012
Last verified: April 2012

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 Intervention Phase
Kidney Cancer
Biological: PEG-interferon alfa-2b
Biological: sargramostim
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Median and progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: April 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00090870     History of Changes
Other Study ID Numbers: CDR0000378049  MUSC-100614  CELGENE-MUSC-100614  MUSC-HR-10423 
Study First Received: September 7, 2004
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Peginterferon alfa-2b
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016