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	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer	Drug: PEG-interferon alfa-2b  Drug: sargramostim  Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: growth factor antagonist therapy  Procedure: interferon therapy  Procedure: non-specific immune-modulator therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-2225,  United States; Recruiting

Study chairs or principal investigators

Uzair B. Chaudhary, MD,  Study Chair,  Medical University of South Carolina   

Study ID Numbers:  CDR0000378049; MUSC-100614; CELGENE-MUSC-100614; MUSC-HR-10423; NCT00090870
Record last reviewed:  August 2004
Last Updated:  February 15, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090870
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08