Kidney Cancer Clinical Trial
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
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.
Full 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 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
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There is 1 Location for this study
Charleston South Carolina, 29425, United States
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