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A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide

NCT03495921 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-04-26

Study results available
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Summary

The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".

Conditions

  • Ewing Sarcoma
  • Ewing Family of Tumors
  • Ewing's Tumor Metastatic
  • Ewing's Sarcoma Metastatic
  • Ewing's Tumor Recurrent
  • Rare Diseases
  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Neoplasms by Histologic Type
  • Neoplasms, Bone Tissue
  • Neoplasms, Connective Tissue
  • Sarcoma, Ewing
  • Neoplasms

Interventions

BIOLOGICAL

Vigil

Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms.

DRUG

Irinotecan

Injectable formulation of irinotecan was distributed from central supplier. 1 Cycle (5 doses of 50 mg/m2 per syringe) was drawn into provided oral syringes and dispenses to the subject with instructions to refrigerate until administration.

DRUG

Temozolomide

Dose: 100 mg/m2 daily, oral Schedule: Days 1-5, every 21 days Administered at least 1 hour before Irinotecan.

Sponsors & Collaborators

  • Gradalis, Inc.

    lead INDUSTRY

Principal Investigators

  • John Nemunaitis, MD · Gradalis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2022-01-20
Completion
2022-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
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 NCT03495921 on ClinicalTrials.gov