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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00324870
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.

Key Dates

Start date
Feb 28, 2006
Status verified
Oct 2013
Primary completion
Jun 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

Primary Outcome Measure

Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II) [ Time Frame: At 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Peninsula Oncology and Hematology PASalisburyMaryland21801-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDPeninsula Oncology and Hematology PA· Salisbury, MDUniversity of Wisconsin Hospital and Clinics· Madison, WI

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