Evidence map›Paper›PMID 19533657›Full record

Trial reportPediatric blood & cancer2009

Phase II evaluation of intravenous vinorelbine (Navelbine) in recurrent or refractory pediatric malignancies: a Children's Oncology Group study.

John F Kuttesch, Mark D Krailo, Timothy Madden, Mary Johansen, Archie Bleyer, Children's Oncology Group

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Pediatric blood & cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003234 (A Phase II Study of Navelbine), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
1.3field-weighted citation impact, top 19% 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.

NCT00003234 phase2completednot on this map

A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies

TypeinterventionalSponsorChildren's Oncology GroupRan1998 to 2007Enrolled50ConditionsBrain and Central Nervous System Tumors, Neuroblastoma, SarcomaArmsvinorelbine tartrate
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Chemotherapy in pediatric low-grade gliomas (PLGG).Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Review
  12. Review
  13. Relapsed Rhabdomyosarcoma.Journal of clinical medicine · 2021
    Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

6 authors at 4 institutions in 1 country.

John F KutteschDepartment of Pediatrics, Vanderbilt School of Medicine and Vanderbilt Ingram Cancer Center, Nashville, Tennessee, USA. john.kuttesch@vanderbilt.edu
Mark D Krailo
Timothy Madden
Mary Johansen
Archie Bleyer
Children's Oncology Group
The University of Texas MD Anderson Cancer Center · USOregon Health & Science University · USUniversity of Southern California · USVanderbilt-Ingram Cancer Center

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543
6 · The paper itself

Abstract

backgroundA Phase II trial was developed to determine the efficacy and toxicity of intravenous vinorelbine, a semi-synthetic vinca alkaloid, in children, adolescent, and young adults with recurrent or refractory solid malignancies. PROCEDURES: Fifty patients were enrolled among three strata: soft tissue sarcomas [rhabdomyosarcoma (RMS), non-rhabdomyosarcoma, primitive neuroepithelial tumor] (20 patients); brain tumors [astrocytoma (4 patients), medulloblastoma (2 patients), other (16 patients)] (22 patients); neuroblastoma (8 patients). Vinorelbine was given weekly for 6 consecutive weeks during an 8-week interval. The response rate and toxicity profile was assessed.

resultsAmong the first 35 patients treated at 33.75 mg/m(2)/dose, 25 experienced grades 3-4 neutropenia (75%). The dose was decreased to 30 mg/m(2)/dose in the remaining 15 patients. The median age was 10 years (range, 1-25). Four responses (one complete, three partial) occurred within the soft tissue sarcoma strata (all with RMS) and two occurred in the brain tumor group (medulloblastoma and astrocytoma). The most common toxicities were hematological and neurological.

conclusionVinorelbine at dose of 30 mg/m(2) can be safely administered to children with recurrent or refractory solid malignancies. The study design identified vinorelbine to be active in the sarcoma category, with a response rate of 36% (4/11) among RMS patients.

Indexed as

AdolescentAdultAntineoplastic Agents, PhytogenicBrain NeoplasmsChildChild, PreschoolFemaleHumansInfantMaleMaximum Tolerated DoseNeoplasm Recurrence, LocalNeuroblastomaRhabdomyosarcomaSarcomaVinblastineAntineoplastic Agents, PhytogenicVinblastineVinorelbine

Identifiers

PMID19533657
PMCPMC2754403
OpenAlexW2093482493

What OpenQuestion holds

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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.