Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma Patients With Disseminated Disease.
Phase 1/Phase 2
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Disseminated Malignant Melanoma
Both
Disseminated Malignant Melanoma
Trial Information
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma Patients With Disseminated Disease.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnancy.
- 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
biobank.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
All cause adverse events
Outcome Description:
Adverse events will be documented such as inflammation, fever, pain, changes in blood pressure, pulse etc.
Outcome Time Frame:
during 10 weeks
Safety Issue:
Yes
Principal Investigator
Thomas H Tötterman, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Uppsala University
Authority:
Sweden: Medical Products Agency
Study ID:
002:CD40L
NCT ID:
NCT01455259
Start Date:
September 2011
Completion Date:
December 2013
Related Keywords:
- Disseminated Malignant Melanoma
- AdCD40L
- Adenoviral vector
- CD40L
- CD154
- malignant melanoma
- Melanoma
Name | Location |
|---|
