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Topoisomerase I inhibitors

Vigil for Sarcoma (VITA Trial)

Phase 3

Waitlist Available

Research Sponsored by Gradalis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of first documented progression (assessed up to 3 years).

Awards & highlights

VITA Trial Summary

This trial is testing a new immunotherapy for people with Ewing's Sarcoma who have not responded to other treatments.

Eligible Conditions

Sarcoma
Connective Tissue Neoplasms
Tumors
Ewing Sarcoma
Bone Tumors
Soft Tissue Tumors
Rare Diseases
Ewing's Tumor
Cancer

VITA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of first documented progression (assessed up to 3 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of first documented progression (assessed up to 3 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented progression (assessed up to 3 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Vigil Manufacture Success Rate: Number of Participants Eligible for Treatment on the Main Study.

VITA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group A: Vigil + Irinotecan and TemozolomideExperimental Treatment3 Interventions

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.

Group II: Cross-Over: Vigil monotherapyExperimental Treatment1 Intervention

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

Group III: Group B: Irinotecan and TemozolomideActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vigil

2016

Completed Phase 3

~250

Temozolomide

2010

Completed Phase 3

~1930

Irinotecan

2017

Completed Phase 4

~2680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gradalis, Inc.Lead Sponsor

15 Previous Clinical Trials

453 Total Patients Enrolled

4 Trials studying Sarcoma

129 Patients Enrolled for Sarcoma

John Nemunaitis, MDStudy DirectorGradalis, Inc.

11 Previous Clinical Trials

460 Total Patients Enrolled

3 Trials studying Sarcoma

29 Patients Enrolled for Sarcoma

Luisa Manning, MDStudy DirectorGradalis, Inc.

7 Previous Clinical Trials

148 Total Patients Enrolled

3 Trials studying Sarcoma

29 Patients Enrolled for Sarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main reason why Vigil is given to patients?

"Vigil has received FDA approval for the treatment of melanoma, as well as other malignant neoplasms like primary central nervous system lymphoma and soft tissue sarcoma."

Answered by AI

Could you explain the possible side effects of Vigil?

"The safety of Vigil is estimated to be a 3 on a scale from 1 to 3. This is because it is a Phase 3 trial, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Has the Vigil drug been studied before in other medical trials?

"The first Vigil clinical trial was completed over 19 years ago at Mayo Clinic in Rochester. 781 studies have been conducted in total. As of now, 464 are recruiting patients with many recruitment centres located in Jacksonville, Florida."

Answered by AI

Could you please tell me how many different locations are participating in this trial?

"There are 17 enrolling clinical sites for this study, which include Mayo Clinic Florida in Jacksonville, Dana-Farber/Boston Children's Cancer and Blood Disorders in Boston, and Cincinnati Children's Hospital Medical Center in Cincinnati."

Answered by AI

How many individuals are participating in this clinical trial?

"This trial is not recruiting at the moment. According to the latest update on February 9th, 2022, this clinical study was first posted on August 21st, 2018. If you are looking for other studies to participate in, there are currently 2897 trials for ewing sarcoma and 464 for Vigil that are actively enrolling patients."

Answered by AI

Are people currently enrolling in this trial?

"This particular clinical trial is not recruiting patients at the moment, as per the information available on clinicaltrials.gov. The said website also notes that this study was first posted on 8/21/2018 and last updated on 2/9/2022. There are 3361 other trials seeking participants currently."

Answered by AI