Conditions: Renal Cell Carcinoma
Keywords: kidney cancer renal cell
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 11
Healthy volunteers: no

Brief summary:
To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.

Detailed description:
In this study, the investigator will assess progression-free and overall survival of patients with advanced renal cell carcinoma treated with 5-azacitidine in combination with bevacizumab. Patients will continue on treatment until either disease progression or development of other criteria for withdrawal.

Arms:
arm 1: A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.

Interventions: intervention 1: Bevacizumab intervention 2: Azacitidine
Intervention descriptions: intervention 1: * First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes.
* Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes.
* Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles). intervention 2: * Dose level 1: 35 mg/m2/day for 7 days.
* Dose level 2: 55 mg/m2/day for 7 days.
* Dose level 3: 75 mg/m2/day for 7 days.

  * mg/m2/day = dose based on height and weight

Protocol document: