Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01243359
Phase
PHASE1
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage I Renal Cell Cancer
  • Stage II Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • sunitinib malate — DRUG
    Given PO
  • bevacizumab — BIOLOGICAL
    Given IV
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • fluorine F 18 fluorothymidine — OTHER
    Undergo FLT PET/CT
  • positron emission tomography — PROCEDURE
    Undergo FLT PET/CT
  • computed tomography — PROCEDURE
    Undergo FLT PET/CT

Study Details

This phase I trial studies the side effects and the best dose of sunitinib malate when given together with bevacizumab in treating patients with kidney cancer or advanced solid malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Nov 18, 2010
Start date
Oct 31, 2010
Status verified
Oct 2013
Primary completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: Treatment (sunitinib malate, bevacizumab)
    Patients receive sunitinib malate PO on days 1-28 and bevacizumab IV over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of patients with grade 3 or higher toxicities and recommended phase II dose of sunitinib in the presence of bevacizumab or sunitinib alone graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 6 weeks ]

Locations (2)

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

Find similar trials in Baltimore, MD

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

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