NCT03338777

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

October 10, 2017

Last Update Submit

February 21, 2020

Conditions

Melanoma

Keywords

melanomalipoplexesplasmidherpes simplex thymidine kinaseinterleukin-2granulocyte-macrophage colony-stimulating factortumor vaccinesuicide gene

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Suicide plus immunogene therapyBIOLOGICAL

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).

Suicide plus immunogene therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ventura Simonovich, MD

    Hospital Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Suicide plus immunogene therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 10, 2017

First Posted

November 9, 2017

Study Start

February 20, 2020

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)