A Clinical Study with one treatment group to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Human Tumor Cells for the Expression of Immunostimulatory molecules in Combination with a DNA-based Immunomodulator in Patients with Advanced Kidney Cancer
- Conditions
- Advanced renal cell carcinomaMedDRA version: 17.0Level: PTClassification code 10038394Term: Renal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016853-16-DE
- Lead Sponsor
- MOLOGEN AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19
1.Male and female subjects older than 18 years of age
2.Histologically confirmed renal cell carcinoma
3.Radiologically confirmed advanced disease defined as unresectable locally reccurrent or metastatic disease (AJCC Stage IV)
4.Previous nephrectomy
5.No standard therapy is available for the patient
6.At least 4 weeks after previous radiotherapy prior to study treatment
7.At least 1 week after previous systemic therapy prior to study treatment
8.At least one lesion measurable by modified RECIST criteria
9.ECOG performance status 0-1
10.Adequate organ function including hematopoietic organs
11.MSKCC prognostic ctiteria < 3 predictors of short survival
12.Negative urine pregnancy test in women with childbearing potential
13.Women of childbearing potential and all male participants are willing to use acceptable methods of contraception (birth control pills, barriers)
14.Expected adequacy of follow-up
15.Signed informed consent form (ICF).
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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Clinically significant concomitant diseases or conditions unrelated to the underlying malignancy or therapy, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
2.Known hypersensitivity to any component of the study drug
3.Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
4.Active brain metastases except adequately treated brain metastases with no progression for at least 3 months
5.Active or uncontrolled infections
6.Transfusion-dependent anemia
7.History of autoimmune disease or immune deficiency
8.Concurrent chronic systemic immune therapy, corticosteroids or other immunosuppressant medication
9.Concurrent radiotherapy within the last 4 weeks prior to study treatment and/or during the course of the study
10.Concurrent immunotherapy or targeted therapy within the last 1 week prior to study treatment and/or during the course of the study
11.HIV seropositivity or active hepatitis B or C infection
12.Planned major surgery during the study
13.Participation in other clinical studies during this clinical study
14.Vaccination within 3 months prior to the first treatment day
15.Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
16.Pregnancy and/or nursing
17.Presence of drug and/or alcohol abuse
18.Commitment to an institution by virtue of an order issued either by judicial or administrative authorities.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method