Suicide Plus Immune Gene Therapy for Advanced Melanoma (IGTM-101)
|ClinicalTrials.gov Identifier: NCT03338777|
Recruitment Status : Terminated (Failure to achieve primary objective)
First Posted : November 9, 2017
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Suicide plus immunogene therapy||Early Phase 1|
This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.
This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.
The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Suicide plus immunogene therapy|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma|
|Actual Study Start Date :||February 20, 2020|
|Actual Primary Completion Date :||February 20, 2020|
|Actual Study Completion Date :||February 20, 2020|
Experimental: Suicide plus immunogene therapy
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
- Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 1 year ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338777
|Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina|
|Principal Investigator:||Ventura Simonovich, MD||Hospital Italiano|