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PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: September 7, 2004   Last Updated: February 6, 2009   History of Changes
Sponsored by: Medical University of South Carolina
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00090870
  Purpose

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 II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Thalidomide Interferon alfa-2a Granulocyte-macrophage colony-stimulating factor Interferon alfa-2b Sargramostim Peginterferon Alfa-2b Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

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
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine ≤ 2.0 mg/dL

Immunologic

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090870

Locations
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
Investigators
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000378049, MUSC-100614, CELGENE-MUSC-100614, MUSC-HR-10423
Study First Received: September 7, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00090870     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Interferon-alpha
Urinary Tract Neoplasm
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
Peginterferon alfa-2b
Carcinoma, Renal Cell
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
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
Angiogenesis Modulating Agents
Kidney Diseases
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Peginterferon alfa-2b
Adenocarcinoma
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on May 06, 2009