Clinical trial using gene therapy (AdCD40L) to treat patients with skin cancer (malignant melanoma)
- Conditions
- malignant melanomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023103-94-SE
- Lead Sponsor
- ppsala University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Histologically proven diagnosis of malignant melanoma, ECOG 0-2.
2. Disease progression on established treatments.
3. Disseminated disease with at least 2 measurable tumor lesions.
4. Signed informed consent must be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Pregnancy.
2. Other malignancy within 5 years of study.
3. Life expectancy less than 3 months.
4. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
5. Patients with severe systemic autoimmune disease.
6. Patients that do not consent to that tissue and blood samples are stored in a biobank.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - Establish CD40L transgene expression<br>- Evaluate systemic exposure of vector<br>- Evaluate immune profile shifts post treatment<br>- Tumor response<br>;Main Objective: Part 1 - To evaluate the feasibility of repeated intra-tumor AdCD40L injections of malignant melanoma patients with metastases by studying tolerance and toxicity.<br><br>Part 2 - To evaluate the feasibility of repeated local treatment of cyclophosphamide preconditioned malignant melanoma patients with metastases by studying the tolerance and toxicity during and after repeated cycles of AdCD40L injections.<br>;Primary end point(s): - Registration of the safety profile such as local inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.<br><br>;Timepoint(s) of evaluation of this end point: 3, 5 and 9 weeks post treatment initiation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Determination of the level of CD40L (mRNA and protein) in blood and biopsies<br>- Determination of the vector level (DNA) in blood and biopsies<br>- Determination of the presence of immunological markers for anti-tumor responses in blood and biopsies.<br>- Determination of tumor size and the tumor marker S100. <br><br>;Timepoint(s) of evaluation of this end point: 3, 5 and 9 weeks post treatment initiation