Suicide Plus Immune Gene Therapy for Advanced Melanoma | NCT03338777 | Trialant

Suicide Plus Immune Gene Therapy for Advanced Melanoma | NCT03338777 | Trialant

Sponsor/Collaborators Module

Collaborators

Name	Class
Instituto de Oncología Ángel H. Roffo	OTHER
National Agency for Scientific and Technological Promotion, Argentina	OTHER
National Council of Scientific and Technical Research, Argentina	OTHER_GOV

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suicide plus immunogene therapy	Experimental	Intra and peritumoral infiltrates with multiple injections of lipoplexes carrying the HSVtk suicide gene co-administered with GCV and subcutaneous vaccine produced with formolized allogeneic tumor extracts and lipoplexes carrying hIL-2 and hGM-CSF genes.	Biological: Suicide plus immunogene therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Suicide plus immunogene therapy	Biological	Intra and peritumoral infiltrates with multiple injections of 0.1 ml/cm2 or 0.2 ml/cm3 of lipoplexes bearing the HSVtk suicide gene (1: 1; 1 mg/ml, according to tumor size), co-administered with GCV (12.5 mg/ml). Patients start with a minimum of 0.5 ml and at the 3rd week, the maximum dose is scaled according to the tumor size up to 2 ml maximum. Treated simultaneously with a subcutaneous vaccine produced with: Formolized allogeneic tumor extracts and, Lipoplexes carrying hIL-2 and hGM-CSF genes (0.5 mg each).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03	Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE\_4.03\_2010-06-14\_QuickReference\_5x7.pdf).	1 year

Eligibility Module

Contacts/Locations Module

Condition Browse Module