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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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?".

Key Dates

Start date

Aug 21, 2018

Status verified

Apr 2023

Primary completion

Jan 20, 2022

Completion

Jan 20, 2022

Study Design

Enrollment

32 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A: Vigil + Irinotecan and Temozolomide
  Participants randomized to Group A received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle). Vigil immunotherapy was administered at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. 1 cycle = 21 days Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.
• Active Comparator: Group B: Irinotecan and Temozolomide
  Participants randomized to Group B received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle). 1 cycle = 21 days Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.
• Other: Cross-Over: Vigil monotherapy
  Participants randomized to Group B were able to receive Vigil immunotherapy at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. Confirmation of progression by central radiologist and pre-approval from sponsor was required. 1 cycle = 21 days

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression (assessed up to 3 years). ]

Locations (15)

Find similar trials in Little Rock, AR

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