TerminatedPhase 3

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

Stopped: Slow accrual and as a result, a strategic business decision was made to terminate enrollment.

United States32 participantsStarted 2018-08-21

Plain-language 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?".

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed Ewing's Sarcoma Family of Tumors (ESFT).
✓. Age greater than or equal to 2 years.
✓. Estimated survival greater than or equal to 6 months.
✓. Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS). If available, NGS sequencing report should be submitted to Gradalis.
✓. Recurrence or refractory to 1 line of systemic chemotherapy, including but not limited to doxorubicin, vincristine, and ifosfamide.
✓. Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of \~10-30 grams tissue ("grape" to "golf-ball" size / approximately 2 cm total diameter on imaging) or pleural fluid estimated volume ≥ 500mL (from a primary or secondary thoracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
✓. Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
✓. Ability to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.

What they're measuring

Progression Free Survival (PFS)

Timeframe: From date of randomization until the date of first documented progression (assessed up to 3 years).

Trial details

NCT IDNCT03495921

SponsorGradalis, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-20

Results submitted2023-01-24

View on ClinicalTrials.gov More Ewing Sarcoma trials

Plain-language summary

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed Ewing's Sarcoma Family of Tumors (ESFT).
✓. Age greater than or equal to 2 years.
✓. Estimated survival greater than or equal to 6 months.
✓. Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS). If available, NGS sequencing report should be submitted to Gradalis.
✓. Recurrence or refractory to 1 line of systemic chemotherapy, including but not limited to doxorubicin, vincristine, and ifosfamide.
✓. Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of \~10-30 grams tissue ("grape" to "golf-ball" size / approximately 2 cm total diameter on imaging) or pleural fluid estimated volume ≥ 500mL (from a primary or secondary thoracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
✓. Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
✓. Ability to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria