Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00126490
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • Aldesleukin — BIOLOGICAL
    Given subcutaneously
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. 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 tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.

Key Dates

First listed
Aug 4, 2005
Start date
Mar 31, 2005
Status verified
Dec 2013
Primary completion
Jun 30, 2012
Completion
Aug 31, 2013

Study Design

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

Arms

  • Experimental: Treatment (bevacizumab, aldesleukin)
    Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

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By research site
Moffitt Cancer Center· Tampa, FL

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