Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma Patients With Disseminated Disease.
- Histologically proven diagnosis of malignant melanoma, ECOG 0-2.
- Disease progression on established treatments.
- Disseminated disease with at least 2 measurable tumor lesions.
- Signed informed consent must be obtained.
- Other malignancy within 5 years of study.
- Life expectancy less than 3 months.
- Any significant medical or psychiatric illness that would prevent the patient from
giving informed consent or from following the study procedures.
- Patients with severe systemic autoimmune disease.
- Patients that do not consent to that tissue and blood samples are stored in a
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
All cause adverse events
Adverse events will be documented such as inflammation, fever, pain, changes in blood pressure, pulse etc.
Outcome Time Frame:
during 10 weeks
Thomas H Tötterman, MD, PhD
Sweden: Medical Products Agency
- Disseminated Malignant Melanoma
- Adenoviral vector
- malignant melanoma