Vorinostat in Treating Patients With Kidney Cancer
Condition: Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Vorinostat
Intervention description: Given orally
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well vorinostat works in treating patients with advanced
      kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma
             that is either metastatic or inoperable

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy
             OR new diagnosis in previously untreated patients who are not appropriate candidates
             to receive IL-2 based treatment

          -  Patients who have failed up to 4 lines of prior immunotherapy or biological therapy
             allowed

          -  No known brain metastases or leptomeningeal disease

          -  Stable brain metastases or curatively resected brain metastases without neurologic
             dysfunction for ≥ 6 months allowed

          -  ECOG performance status 0-2 OR Karnofsky 70-100%

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 50
             mL/min

          -  Total bilirubin within normal limits

          -  AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)

          -  No history of active malignancy (other than renal cell carcinoma) within the past 3
             years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ
             cervical cancer

          -  No history of allergic reactions to compounds of similar chemical or biological
             composition to vorinostat (SAHA)

          -  No uncontrolled concurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No clinically significant hypercalcemia

          -  No significant traumatic injury within the past 21 days

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No gastrointestinal disease resulting in an inability to take oral medication

          -  No requirement for IV alimentation

          -  No active peptic ulcer disease

          -  Recovered from prior therapy

          -  Prior nephrectomy or resection of metastatic lesions allowed provided full surgical
             recovery has occurred

          -  No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)

          -  No radiotherapy within the past 4 weeks

          -  No valproic acid for at least 2 weeks prior to study enrollment

          -  No prior surgical procedures affecting absorption

          -  No major surgery within the past 21 days

          -  No concurrent antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy