Evidence map›Paper›PMID 36780200›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Pilot Study of Recurrent Ewing's Sarcoma Management with Vigil/Temozolomide/Irinotecan and Assessment of Circulating Tumor (ct) DNA.

Peter Anderson, Maurizio Ghisoli, Brian D Crompton, Kelly S Klega, Leonard H Wexler, Emily K Slotkin, Laura Stanbery, Luisa Manning, Gladice Wallraven, Meghan Manley and 3 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07695311 (Precision Analysis of Fusion Genes in Ewing Sarcoma), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07695311 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Precision Analysis of Fusion Genes in Ewing Sarcoma (ES) and Desmoplastic Small Round Cell Tumor (DSRCT), Then EWSR1 (Ewing Sarcoma Gene Breakpoint Region 1 Gene) Immunotherapy Without or With Anti-CTLA-4 (Botensilimab) and Anti-PD1 (Balstilimab)

TypeinterventionalSponsorRabi HannaRan2026 to 2030Enrolled24ConditionsEwing Sarcoma, Desmoplastic Small Round Cell TumorArmsEWSR1 immunotherapy, Botensilimab, Balstilimab
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Preclinical assessment of GNEFuture science OA · 2026
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
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  12. Cellular crosstalk in the bone marrow niche.Journal of translational medicine · 2024
    Review
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  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Peter AndersonCleveland Clinic, Cleveland, Ohio.ORCID 0000-0002-0011-0969
Maurizio GhisoliTexas Oncology P.A., Dallas, Texas.ORCID 0000-0001-7055-2618
Brian D CromptonDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0001-9404-6621
Kelly S KlegaDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-3424-2003
Leonard H WexlerMSK KIDS, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-0724-8263
Emily K SlotkinMSK KIDS, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-4463-5759
Laura StanberyGradalis, Inc., Carrollton, Texas.ORCID 0000-0001-7251-4076
Luisa ManningGradalis, Inc., Carrollton, Texas.ORCID 0000-0001-8568-1535
Gladice WallravenGradalis, Inc., Carrollton, Texas.ORCID 0000-0002-2145-3565
Meghan ManleyGradalis, Inc., Carrollton, Texas.ORCID 0000-0002-8600-8286
Staci HorvathGradalis, Inc., Carrollton, Texas.ORCID 0000-0003-0181-8448
Ernest BognarGradalis, Inc., Carrollton, Texas.ORCID 0000-0003-0314-7529
John NemunaitisGradalis, Inc., Carrollton, Texas.ORCID 0000-0002-2234-2381
National Athletic Trainers Association · USDana-Farber Cancer Institute · USMemorial Sloan Kettering Cancer Center · USCleveland Clinic · USTexas Oncology · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeTreatment options for recurrent or refractory Ewing's sarcoma (ES) are limited. Vigil is a novel autologous tumor cell therapy expressing bi-shRNA furin/GMCSF plasmid, which previously demonstrated monotherapy activity in advanced ES. Herein we report safety and evidence of benefit to Vigil for ES as potential treatment. PATIENTS AND

methodsIn this pilot trial, eligible patients with recurrent or refractory ES who failed initial standard-of-care therapy received treatment with temozolomide (TEM) 100 mg/m2/day oral and irinotecan (IRI) 50 mg/m2/day oral, Days 1 to 5, in combination with Vigil (1 × 106-107 cells/mL/day intradermal, Day 15), every 21 days (Vigil/TEM/IRI). Objective response rate (ORR) by RECIST v1.1, progression-free survival (PFS), and overall survival (OS) were assessed. Circulating tumor (ct) DNA analysis was done by patient-specific droplet digital PCR on baseline and serially collected on-treatment samples.

resultsEight of 10 enrolled patients were evaluable for safety and efficacy (mean age 24.6; 12.6-46.1 years old); 2 did not receive Vigil. Seven of 8 patients previously received TEM/IRI. No Vigil-related adverse events were reported. Common ≥Grade 3 chemotherapy-related toxicity included neutropenia (50%) and thrombocytopenia (38%). We observed two partial response patients by RECIST; both showed histologic complete response without additional cancer therapy. Median PFS was 8.2 months (95% confidence interval, 4.3-NA). Five patients showed stable disease or better for ≥6 months. Patient-specific EWS/FLI1 ctDNA was detectable in all 8 evaluable patients at baseline. Changes in ctDNA levels corresponded to changes in disease burden.

conclusionsResults demonstrated safety of combination Vigil/TEM/IRI.

Indexed as

Circulating Tumor DNASarcoma, EwingAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsChildHumansIrinotecanMiddle AgedModafinilNeoplasm Recurrence, LocalPilot ProjectsTemozolomideYoung AdultCirculating Tumor DNAIrinotecanModafinilTemozolomide

Identifiers

PMID36780200
PMCPMC10150239
OpenAlexW4320486355

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.