Treatment of metastatic renal cell carcinoma by dendritic cells vaccination.

Treatment of metastatic renal cell carcinoma using interleukin-12 secreting dendritic cells. Phase I/II clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004391-11-CZ

Enrollment

Registered

2011-09-14

Start date

2012-02-08

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metatastic renal cell carcinoma

Interventions

Product Name: Dendritic cells producing IL-12 Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 180 mm Hg and/or diastolic >100 mm Hg). • Sero-positivity for HIV1, 2, Treponema pallidium or active Hepatitis B or C infection.

Design outcomes

Primary

Measure	Time frame
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. • Overall survival (OS) in patients with mRCC. • Quality of life in patients treated with DC vaccination. • 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. ;Primary end point(s): Safety of DC vaccination when combined with Sunitinib/Sorafenib. Progression free survival (PFS) Best overall response (BOR) ;Timepoint(s) of evaluation of this end point: 12 months after diagnosis	—

Measure

Time frame

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. • Overall survival (OS) in patients with mRCC. • Quality of life in patients treated with DC vaccination. • 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. ;Primary end point(s): Safety of DC vaccination when combined with Sunitinib/Sorafenib. Progression free survival (PFS) Best overall response (BOR) ;Timepoint(s) of evaluation of this end point: 12 months after diagnosis

—

Secondary

Measure	Time frame
Secondary end point(s): Quality of life in patients treated with DC vaccination. 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. ;Timepoint(s) of evaluation of this end point: 12 months after diagnosis	—

Countries

Czech Republic

Contacts

Public ContactDepartment of Pharmacology

Masaryk University

demlova@med.muni.cz00420549493070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026