- Test the hypothesis that combination biotherapy with aflibercept and HD IL-2 will improve the progression-free survival compared to HD IL-2 alone.
- Evaluate the response rate (CR+PR) of aflibercept and HD IL-2 as assessed by RECIST criteria version 1.1 and compare to HD IL-2 alone.
- Evaluate the toxicities and tolerance of combination biotherapy with aflibercept and HD IL-2 and maintenance aflibercept alone in this patient population and compare to HD-IL2 alone.
- Test the hypotheses related to the laboratory correlative studies.
- Evaluate the overall survival of patients treated with aflibercept and HD IL-2 and HD IL-2 alone.
OUTLINE: This is a multicenter study. Patients are stratified according to visceral disease (present vs absent), Karnofsky performance status (0 vs 1), and gender (male vs female). Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive aflibercept IV over at least 1 hour in weeks 1, 3, 5, and 7 (and in week -1 of course 1 only) and high-dose aldesleukin IV over 15 minutes every 8 hours for 5 days in weeks 1 and 3. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising aflibercept IV on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Arm B: Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours for 5 days in weeks 1 and 3. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for laboratory correlative studies.
After completion of study treatment, patients are followed up every 3-4 months for 5 years.
PROJECTED ACCRUAL: A total of 105 patients (70 on arm A and 35 on arm B) will be accrued for this study.
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