Treatment of metastatic renal cell carcinoma by dendritic cells vaccination.

Phase 1

• Conditions: Metatastic renal cell carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004391-11-CZ
• Lead Sponsor: Masaryk University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-14
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Male and female patients, aged between 18-80 years.
•Eligible for TKI treatment with Sunitinib or Sorafenib according the doctor's instructions.
•The patients must undergo nephrectomy or nephron-sparing surgery or metastasectomy.
•At least one measurable lesion at baseline as per the RECIST criteria, determined by CT scan or MRI.
•ECOG performance status 0-1.
•Histologically confirmed clear cell mRCC after surgery is necessary.
•Written informed consent obtained prior to study entry.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Pregnancy or nursing.
•Prior immune suppressive therapy (less than 4 week before screening).
•Evidence of an active infectious disease or active autoimmune disease.
•Other malignancies within the last 5 years.
•Renal insufficiency requiring haemodialysis.
•Impaired renal function (serum creatinine >2.0 times upper limit of normal (ULN).
•Impaired hepatic function (ALT or AST >2.5 times ULN).
•At least two out of three positive risk factors (modified from Molina et al.):
•Lactate dehydrogenase >1.5 times ULN;
•Serum calcium >2.5 mmol/l
•Haemoglobin < 120 g/l (in women), < 130 g/l (in men).
•Impaired haematological parameters, including WBC < 4x109/l, haemoglobin < 100 g/l, or platelet count <100x109/l.
•History of significant cardiovascular disease (myocardial infarct <3 months, unstable angina, NYHA (New York Heart Assotiation) class II-IV, serious cardiac arrhythmia requiring medication).
•Untreated hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg).
•Sero-positivity for HIV1, 2, Treponema pallidium or active Hepatitis B or C infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study objective of the RCC-DC-2011 trial are to evaluate efficacy and safety of IL-12 producing DC vaccination in patients with metastatic renal cell carcinoma who are treated with Sunitinib or Sorafenib as the first line standard treatment.;Secondary Objective: •Progression-free survival (PFS) 12 months after diagnosis of mRCC.<br>•Overall survival (OS) in patients with mRCC.<br>•Quality of life in patients treated with DC vaccination.<br>•Immune response demonstrated by delayed type hypersensitivity (DTH) testing before, during and after the vaccination course, and by testing specific immune response in in vitro assays.<br>;Primary end point(s): Safety of DC vaccination when combined with Sunitinib/Sorafenib.<br>Progression free survival (PFS)<br>Best overall response (BOR)<br>;Timepoint(s) of evaluation of this end point: 12 months after diagnosis<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life in patients treated with DC vaccination.<br>Immune response demonstrated by delayed type hypersensitivity (DTH) testing before, during and after the vaccination course, and by testing specific immune response in in vitro assays.<br>;Timepoint(s) of evaluation of this end point: 12 months after diagnosis<br>