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Suicide Plus Immune Gene Therapy for Advanced Melanoma

NCT03338777 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-02-25

No results posted yet for this study

Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Instituto de Oncología Ángel H. Roffo

    collaborator OTHER

  • National Agency for Scientific and Technological Promotion, Argentina

    collaborator OTHER

  • National Council of Scientific and Technical Research, Argentina

    collaborator OTHER_GOV

  • University of Buenos Aires

    collaborator OTHER

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Ventura Simonovich, MD · Hospital Italiano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2020-02-20
Completion
2020-02-20

Countries

  • Argentina

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338777 on ClinicalTrials.gov