Phase I dose-escalation trial for the combination of sorafenib with interleukin-2 (IL-2) in patients with clear cell renal cancer
- Conditions
- kidney cancerrenal cancer1002747610046400
- Registration Number
- NL-OMON30060
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Patients with cytologically or histologically proven RCC, clear cell subtype, with documented progressive disease either after first line, interferon(IFN)-a- or interleukin-2-based therapy or for whom IFN-a-based treatment is not considered appropriate because of prognostic features according to Motzer.
- Evaluable and measurable disease (according to RECIST criteria)
- PF 0-1
- Adequate bone marrow, hepatic and renal function
- life expectancy of at least 3 months
- age of 18 or older
- willingness to use a medically approved method of contraception
- before patient randomization, written informed consent must be given and documented to ICH/EU GCP, and national/local regulatory requirements and the local rules followed in the institution
- Uncontrolled or poorly controlled hypertension (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 90 mmHg). Initiation or adjustment of blood pressure medications is permitted prior to study treatment provided that 3 consecutive blood pressure readings are <= 150/90 mmHg, each separated by at least 24 hours
- Concurrent therapy with prohibited medication
- History of malabsorption syndrome or other disease that could significantly affect absorption of drugs
- Other malignancies (previous or current), except adequately treated basal or squamous cell carcinoma of the skin and carcinoma in situ of breast or cervix
- Prior treatment with VEGF or VEGF-R targeting agent (monoclonal antibody or tyrosine kinase inhibitor)
- Cytotoxic, hormonal, investigational treatment or immunotherapy within 4 weeks prior to day 1 of study treatment
- Major surgery within 4 weeks prior to study treatment
- Persistent grade 2 or greater toxicity related to prior treatment (except alopecia) (NCI-CTC version 3.0)
- History of any infection requiring hospitalisation or antibiotics within 2 weeks prior to study treatment
- Systemic steroids within 2 weeks prior to study treatment
- Myocardial infarction or cerebrovascular accident (CVA) within 6 months prior to study treatment
- Congestive heart failure requiring medication
- Known brain metastases
- Known human immunodeficiency virus (HIV) infection
- Known chronic or acute viral hepatitis
- Pregnant or breast-feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method