Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: Everolimus; imatinib mesylate
Intervention description: 2.5 mg by mouth daily; 600 mg by mouth daily
Intervention MeSH terms: Everolimus; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: stage III renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer

Summary:

      RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Everolimus may also block blood flow to the
      tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib
      mesylate works in treating patients with metastatic or unresectable kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed clear cell kidney cancer, meeting 1 of the following
             criteria:

               -  Measurable metastatic disease

               -  Locally unresectable disease

          -  No history of known brain metastases that have not been adequately treated with
             radiotherapy and/or surgery

          -  Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal
             cell carcinoma

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Hemoglobin > 8 g/dL

          -  Bilirubin < 1.5 times upper limit of normal (ULN)

          -  Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic
             transaminase(SGPT) < 2.5 times ULN

          -  Creatinine < 1.5 times ULN

          -  No New York Heat Association grade III-IV cardiac disease

          -  No other malignancy within the past 5 years except basal cell skin cancer, cervical
             carcinoma in situ, or insignificant or inactive disease

          -  No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

          -  No severe or uncontrolled medical disease

          -  No gastrointestinal disease or impairment that would hinder the absorption of
             everolimus

          -  No uncontrolled diabetes

          -  No chronic renal disease

          -  No active uncontrolled infection

          -  No congestive heart failure

          -  No myocardial infarction within the past 6 months

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 2 weeks since prior major surgery

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C)

          -  More than 4 weeks since prior immunotherapy

          -  More than 4 weeks since other prior investigational agents

          -  No prior radiotherapy to > 25% of bone marrow

          -  No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor

          -  No concurrent therapeutic warfarin