A Phase 2 interventional study of aldesleukin and bevacizumab in Kidney Cancer, sponsored by Jonsson Comprehensive Cancer Center. Status unknown at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 65 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
FEV_1 ≥ 2.0 L or ≥ 75% of predicted
No evidence of any of the following cardiac conditions*:
No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ
No history of inflammatory bowel disease or other serious autoimmune disease
PRIOR CONCURRENT THERAPY:
Response
Progression-free and overall survival
Comparison of response and survival with historical data
Toxicity
Time to disease progression
Pharmacokinetics and pharmacodynamics
Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival
Utility of known prognostic criteria
This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jonsson Comprehensive Cancer Center