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

  • STATUS
    Recruiting
  • participants needed
    65
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 7 November 2020
diabetes
platelet count
hypertension
white blood cell count
monoclonal antibodies
carcinoma
interleukin-2
arrhythmia
metastasis
neutrophil count
tumor cells
bevacizumab
carcinoma in situ
cervical carcinoma in situ
aldesleukin
metastatic renal cell carcinoma

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

Description

OBJECTIVES: Primary - Estimate the response, progression-free survival, and overall survival of patients with metastatic renal cell carcinoma (RCC) treated with bevacizumab and high-dose interleukin-2 (IL-2). Secondary - Compare the response and survival of patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone. - Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC with the historical data of patients treated with high-dose IL-2 alone, in terms of number of doses of IL-2 administered during the first course of therapy, toxicity after the scheduled ninth dose of IL-2, and frequency of grade III and IV or unexpected or rare toxicities. - Compare the time to disease progression in patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone. - Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2 during course 1. - Correlate serum vascular endothelial growth factor (VEGF) levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival of patients treated with this regimen. - Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome. OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good vs intermediate vs poor). Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71 during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Details
Condition Malignant neoplasm of kidney
Treatment aldesleukin, bevacizumab
Clinical Study IdentifierNCT00301990
SponsorJonsson Comprehensive Cancer Center
Last Modified on7 November 2020

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