A Phase 2 interventional study of Interleukin-2 and Interferon Alfa-2b in Metastatic Renal Cell Carcinoma, sponsored by University of Aarhus. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by University of Aarhus · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether interleukin-2, interferon-alpha in combination with bevacizumab are effective in the treatment of metastatic renal cell carcinoma (mRCC).
Bevacizumab as monotherapy has effect in metastatic renal cell carcinoma (mRCC). Bevacizumab in combination with interferon-alfa (IFN-α) has significant efficacy in mRCC and has been approved by EMA and FDA.
The present study will assess whether the combination of Interleukin-2 (IL-2) and IFN-α with bevacizumab may add efficacy in patients with mRCC with a tolerable safety profile.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 118 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Haematology:
WCC ≥ 3.0 x 109/L, Platelet count ≥ 100 x 109/L, Haemoglobin ≥ 6.2 mmol/l, (INR) ≤ 1.5, APTT ≤ 1.5 x ULN
Biochemistry:
Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST, ALT ≤ 2.5 x ULN in patients without liver metastases, ≤ 5 x ULN in patients with liver metastases, Serum Creatinine ≤ 150 micromol/L
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Exclusion Criteria:
Serial blood test, serial tumor biopsies and serial dynamic contrast-enhanced imaging will be obtained as part of a translational research program integrated in the clinical trial.
Part(s) of the translational research program may be omitted in the individual patient due to practical, technical or safety reasons, without having consequences for participating in the additional translational research investigations or the clinical part of the study.
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Drug: Bevacizumab
Drug: Interleukin-2 · Drug: Interferon Alfa-2b
2.4 MIU/m2 s.c. two times daily, 5 days per week, weeks 1 and 2, every 28-day-cycle, for a maximum of 9 cycles (i.e.for a maximum of 9 months).
Also known as: Aldesleukin
IFN-alfa given as one priming-week of daily IFN 3.0 MIU, followed by up to 9 treatment cycles (i.e. for a maximum of 9 months) with IFN-alfa 3.0 MIU as a fixed dose s.c. once daily - 5 days per week.
Also known as: IntronA
Bevacizumab doses of 10 mg per kilogram of body weight, given every two weeks i.v. until disease progression, unacceptable toxicity, withdrawal of consent or a maximum of 1 year following obtaining no evidence of disease (NED).
Also known as: Avastin
Progression free survival, PFS
Time frame: This is defined as the time between date of randomisation and the first date of documented disease progression or date of death due to any cause.
Response rate, RR
Time frame: Overall response rate as assessed by the RECIST 1.1 criteria. An overall response is defined as a confirmed complete response (CR) or confirmed partial response (PR).
Overall survival, (OS)
Time frame: Overall survival is defined as the time between date of randomisation and the date of death due to any cause.
Duration of response
Time frame: Duration of response is defined as the time between the date a response (CR or PR) was first seen until date of progression.
Time to progression, (TTP)
Time frame: Time to progression is defined as time between date of randomisation and date of documented progression.
Time to treatment failure, (TTTF)
Time to treatment failure is defined as time between date of randomisation and date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawn informed consent.
Time frame: see below
Tolerability
Toxicity is recorded according to CTCAE v3.0
Time frame: see below
Frequency of surgical resection of residual disease
This is calculated as number of patients having surgical resection of residual disease compared with the total number of treated patients.
Time frame: see below
Frequency of no evidence of disease (NED)
This is calculated as the total number of patients having no evidence of disease as a result of CR to treatment, or as a result of PR/SD to treatment followed by surgical resection of residual disease, compared with the total number of treated patients.
Time frame: see below
To explore the immunomodulatory effect of therapy in serial blood samples and serial tumor core biopsies and to correlate these biomarkers with outcome
Blood tests and core biopsies from accessible tumor lesions will be obtained at baseline, after cycle 1 and at PD. Blood analyses will include assessment of dendritic cells, FoxP3+ regulatory T-cells, NK-cells, T-subsets, neutrophils, monocytes, cytotoxic activity and antibody-dependent cellular cytotoxicity (ADCC). Tumor analyses will include assessment of intratumoral immune cells, markers related to HIF accumulation and CD34+ microvessel density.
Time frame: see below
To assess dynamic contrast-enhanced imaging as a potential biomarker.
Dynamic contrast-enhanced imaging (CT, MRI, and US) will be obtained at baseline, week 5 and at routine tumor assessments, if appropriate, for estimation of tumor blood perfusion change. An exploratory analysis to identify any potential relationship between each of these assessments and outcome (progression free survival, survival, time to progression, response rate and safety) will be performed.
Time frame: see below
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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University of Aarhus