Clinical Trial: Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma

Brief Summary:

RATIONALE: 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. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.


Detailed Summary:

OBJECTIVES:

Primary

  • To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.

Secondary

  • To determine the objective response rate in patients receiving this regimen.
  • To determine the time to progression in patients receiving this regimen.
  • To evaluate immunomodulatory effects of this regimen in patients
  • To evaluate the toxicity of this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days -14, 1, 15, 29, and 42 and aldesleukin subcutaneously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving complete response after completion of study therapy may receive 1 additional course of therapy.

After completion of study therapy, patients are followed periodically.


Sponsor: Jorge Garcia, MD

Current Primary Outcome: Progression Free Survival [ Time Frame: From baseline (day -14) to disease progression (reported at 2 years) ]

Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.


Original Primary Outcome: Progression Free Survival

Current Secondary Outcome:

  • Objective Response Rate (Complete and Partial Response) [ Time Frame: 4 weeks after treatment ]
    To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
  • Percentage of Patients With Constitutional Adverse Events [ Time Frame: From start of treatment to 30 days after treatment ]
    Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills
  • Percentage of Patients With Neutropenia [ Time Frame: From start of treatment to 30 days after treatment ]
    Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia


Original Secondary Outcome:

  • Objective Response Rate (Complete and Partial Response)
  • Toxicity


Information By: Case Comprehensive Cancer Center

Dates:
Date Received: February 26, 2009
Date Started: December 2005
Date Completion:
Last Updated: July 28, 2015
Last Verified: July 2015