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Suicide Plus Immune Gene Therapy for Advanced Melanoma (IGTM-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338777
Recruitment Status : Terminated (Failure to achieve primary objective)
First Posted : November 9, 2017
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Instituto de Oncología Ángel H. Roffo
National Agency for Scientific and Technological Promotion, Argentina
National Council of Scientific and Technical Research, Argentina
University of Buenos Aires
Information provided by (Responsible Party):
Simonovich Ventura, MD, Hospital Italiano de Buenos Aires

Brief Summary:
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Suicide plus immunogene therapy Early Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Suicide plus immunogene therapy
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
  1. 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.
  2. 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).




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically and / or cytologically confirmed melanoma.
  • Patients progressed or are intolerant to conventional systemic treatments.
  • Patients that are not candidates for surgery under oncologic criteria (complete resection).
  • Performance status (ECOG) 0 or 1.
  • Patients with life expectancy greater than 6 months.
  • Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis).
  • Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation)
  • Patients with signed informed consent.

Exclusion Criteria:

  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled respiratory disease.
  • Patients with uncontrolled immune disease.
  • Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
  • Patients performing other experimental therapies.
  • Patients who are pregnant or breastfeeding.
  • Patients undergoing concurrent chemotherapy or radiation therapy.
  • Uncontrolled diabetes.
  • Patients with active diagnosis of other malignant neoplasms.
  • HIV-positive patients.
  • Uncontrolled thyroid abnormality.
  • Patients with significant medical morbidity.
  • Patients with a history of allergic reactions to chemicals or similar to those used in this study.
  • Metastasis in the central nervous system.
  • Laboratory eligibility criteria excluded:

    • Hemoglobin: <8 g / dL, leukocytes: <3,000 / mm3, platelets: <100,000 / mm3, neutrophils: <1000 / mm3, hematocrit: <25%. bilirubin> 2.0 mg / dL, GOT or GPT: 2.5 times> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times> ULN, creatinine> 2.0 mg / dL, creatinine clearence : <60 ml / min / 1.73 m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338777


Locations
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Argentina
Hospital Italiano
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Instituto de Oncología Ángel H. Roffo
National Agency for Scientific and Technological Promotion, Argentina
National Council of Scientific and Technical Research, Argentina
University of Buenos Aires
Investigators
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Principal Investigator: Ventura Simonovich, MD Hospital Italiano
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Responsible Party: Simonovich Ventura, MD, Medical Doctor, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03338777    
Other Study ID Numbers: 2082
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Simonovich Ventura, MD, Hospital Italiano de Buenos Aires:
melanoma
lipoplexes
plasmid
herpes simplex thymidine kinase
interleukin-2
granulocyte-macrophage colony-stimulating factor
tumor vaccine
suicide gene
Additional relevant MeSH terms:
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Melanoma
Suicide
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Self-Injurious Behavior
Behavioral Symptoms