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Status:

COMPLETED

Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Clear Cell Renal Cell Carcinoma

Recurrent Renal Cell Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with bevacizumab and to see how well they work in treating patients with unresectable or metastatic k...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the safety and tolerability of vorinostat (SAHA) in combination with bevacizumab in patients with unresectable or metastatic renal cell carcinoma. (Phase I) II. Deter...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • No known CNS metastasis
  • ECOG performance status 0-2
  • Life expectancy \> 6 months
  • LVEF ≥ 45%
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • PT/INR ≤ 1.5
  • Urine protein \< 1+ by urinalysis OR \< 1 g by 24-hour urine collection
  • Not pregnant
  • No nursing during and for 6 months after completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 2 weeks prior, during, and for 6 months after completion of study treatment
  • No other currently active malignancy defined as \> 30% risk of relapse upon completion of anticancer therapy, except nonmelanoma skin cancer
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA)
  • No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No evidence of bleeding diathesis or coagulopathy
  • No active bleeding or pathological conditions that carry high risk of bleeding (i.e., tumor involving major vessels or known varices)
  • No ongoing, active infection
  • No New York Heart Association class II-IV congestive heart failure
  • No angina pectoris requiring nitrate therapy
  • No cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No history of cerebrovascular accident within the past 6 months
  • No uncontrolled hypertension (defined as systolic blood pressure (BP) \> 160 mm Hg and/or diastolic BP \> 90 mm Hg on medication)
  • No history of peripheral vascular disease
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury in the past 28 days
  • At least 4 weeks since prior major surgery or open biopsy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • More than 4 weeks since prior radiotherapy
  • At least 2 weeks since prior tyrosine kinase inhibitor
  • Prior palliative radiotherapy to metastatic lesions allowed provided ≥ 1 measurable and/or evaluable lesion has not been irradiated
  • No more than 2 prior systemic treatments for metastatic disease, including immunotherapy, receptor tyrosine kinase inhibitor therapy, chemotherapy, or investigational therapy
  • No prior therapy with bevacizumab, vascular endothelial growth factor-trap, or histone deacetylase inhibitors, including valproic acid
  • No core biopsy within 1 week prior to day 1 of study treatment
  • No planned major surgery during study treatment
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • Concurrent stable-dose prophylactic anticoagulation (i.e., warfarin or low molecular weight heparin) allowed provided requirements for INR are met
  • Histologically confirmed renal cell carcinoma, clear cell component, unresectable or metastatic disease (patients with a primary tumor in place who are eligible for surgery are strongly encouraged to undergo a nephrectomy prior to study entry to increase potential survival)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
  • The following histologies are not allowed:
  • Papillary, sarcomatoid carcinoma
  • Chromophobe carcinoma
  • Oncocytoma
  • Collecting duct tumor
  • Transitional cell carcinoma
  • WBC ≥ 3,000/mm\^3

Exclusion

    Key Trial Info

    Start Date :

    February 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2013

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00324870

    Start Date

    February 1 2006

    End Date

    November 1 2013

    Last Update

    January 13 2016

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, United States, 21287

    2

    Peninsula Oncology and Hematology PA

    Salisbury, Maryland, United States, 21801

    3

    University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, United States, 53792