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Topoisomerase I inhibitors

Vigil for Solid Tumors (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

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if adding Vigil to standard cancer drugs can help patients with metastatic Ewing's sarcoma who haven't responded to previous treatments. Vigil is made from the patient's own tumor cells to boost the immune system's ability to fight cancer.

Eligible Conditions

Solid Tumors
Sarcoma
Connective Tissue Neoplasms
Tumors
Soft Tissue Tumors
Ewing's Tumor
Ewing Sarcoma
Rare Disease
Ewing's tumor
Cancer
Neoplasm
Rare Diseases
Bone Cancer
Ewing's sarcoma
Lymphoma
Bone Tumors

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1880