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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: PEG-interferon alfa-2b
* Biological: GM-CSF
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-Intron, BM-CSF and thalidomide<br> | Biological: PEG-interferon alfa-2b<br>* Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.<br>Biological: GM-CSF<br>* GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle<br>Drug: thalidomide<br>* 200mg daily by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide | while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response |  | time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment. | 
| Frequency of Adverse Events Assessed by NCI CTC Version 2 |  | From the first day of treatment until the end of treatment visit, an average of 6 months | 
| Progression-free Survival |  | From registration until diease progression or death, whichever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer