PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: PEG-interferon alfa-2b; GM-CSF; thalidomide
Intervention description: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.; GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle; 200mg daily by mouth
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Thalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV renal cell 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.
    

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