Evidence map›Paper›PMID 25307519›Full record

ArticlePediatric blood & cancer2015

Phase I trial of Seneca Valley Virus (NTX-010) in children with relapsed/refractory solid tumors: a report of the Children's Oncology Group.

Michael J Burke, Charlotte Ahern, Brenda J Weigel, John T Poirier, Charles M Rudin, Yingbei Chen, Timothy P Cripe, M Brooke Bernhardt, Susan M Blaney

Abstract readClinical Trial, Phase I
In one paragraph

Article in Pediatric blood & cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Translation of oncolytic viruses in sarcoma.Molecular therapy. Oncology · 2024
    Review
  10. Exploring treatment options in cancer: Tumor treatment strategies.Signal transduction and targeted therapy · 2024
    Review
  11. Neuroblastoma-A Review of Combination Immunotherapy.International journal of molecular sciences · 2024
    Review
  12. Review
  13. Article
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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

9 authors.

Michael J BurkeDepartment of Pediatrics, Division of Hematology/Oncology/BMT, Medical College of Wisconsin, Milwaukee, Wisconsin.
Charlotte Ahern
Brenda J Weigel
John T Poirier
Charles M Rudin
Yingbei Chen
Timothy P Cripe
M Brooke Bernhardt
Susan M Blaney

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Pediatric Pilot/Phase I Consortium - Foreign AccrualU01CA097452 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI BLANEY, SUSAN M. · 2002 to 2011
$28.2M
Pediatric Phase 1/Pilot ConsortiumUM1CA097452 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI WEIGEL, BRENDA J. · 2009 to 2018
$17.7M
NCI NIH HHS P30 CA008748NCI NIH HHS U01 CA097452NCI NIH HHS UM1 CA097452
6 · The paper itself

Abstract

backgroundTo determine the MTD of Seneca Valley Virus (NTX-010) in children with relapsed/refractory solid tumors. Patients (≥ 3-≤ 21 years) with neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features were eligible. PROCEDURE: Part A (single dose of NTX-010) enrolled 13 patients at three dose levels (1 × 10(9) viral particles (vp)/kg [n = 6], 1 × 10(10) vp/kg [n = 3], 1 × 10(11) vp/kg [n = 4]). Diagnoses included neuroblastoma (n = 9), rhabdomyosarcoma (n = 2), carcinoid tumor (n = 1), and adrenocorticocarcinoma (n = 1). Part B added cyclophosphamide (CTX) (oral CTX (25 mg/m(2) /day) days 1-14 and IV CTX (750 mg/m(2) ) days 8 and 29) to two doses of NTX-010 (1 × 10(11) vp/kg, days 8 and 29). Nine patients enrolled to Part B. Diagnoses included neuroblastoma (n = 3), rhabdomyosarcoma (n = 1), Wilms tumor (n = 3), and adrenocorticocarcinoma (n = 2).

resultsTwelve patients on Part A were evaluable for toxicity. There was a single DLT (grade 3 pain) at dose level 1. Additional grade ≥ 3 related adverse events (AEs) included leukopenia (n = 1), neutropenia (n = 3), lymphopenia (n = 3), and tumor pain (n = 1). No DLTs occurred on part B. Other grade ≥ 3 related AEs on Part B included: Leukopenia (n = 3), nausea (n = 1), emesis (n = 1), anemia (n = 1), neutropenia (n = 4), platelets (n = 1), alanine aminotransferase (n = 1), and lymphopenia (n = 2). All patients cleared NTX-010 from blood and stool by 3 weeks with 17/18 patients developing neutralizing antibodies.

conclusionNTX-010 is feasible and tolerable at the dose levels tested in pediatric patients with relapsed/refractory solid tumors either alone or in combination with cyclophosphamide. However, despite the addition of cyclophosphamide, neutralizing antibodies appeared to limit applicability.

Indexed as

Drug Resistance, NeoplasmOncolytic VirotherapyPicornaviridaeSalvage TherapyAdolescentAdultAntibodies, NeutralizingAntineoplastic Agents, AlkylatingChildChild, PreschoolCombined Modality TherapyCyclophosphamideFemaleFollow-Up StudiesHumansMaleAntibodies, NeutralizingAntineoplastic Agents, AlkylatingCyclophosphamideoncolyticpediatricrelapsedseneca valley virussolid tumors

Identifiers

PMID25307519
PMCPMC4376652

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Registered trials

None linked

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.