Evidence map›Paper›PMID 23666235›Full record

ArticleJournal of neuro-oncology2013

Phase I study of temozolomide combined with oral etoposide in children with malignant glial tumors.

Antonio Ruggiero, Daniela Rizzo, Giorgio Attinà, Ilaria Lazzareschi, Palma Maurizi, Vita Ridola, Stefano Mastrangelo, Roberta Migliorati, Patrizia Bertolini, Cesare Colosimo and 1 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of neuro-oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 38% 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.

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

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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

11 authors at 4 institutions in 3 countries.

Antonio RuggieroPediatric Oncology Division, Department of Pediatric Oncology, A Gemelli Hospital, Catholic University of Rome, Largo A Gemelli 1, 00168 Rome, Italy.
Daniela Rizzo
Giorgio Attinà
Ilaria Lazzareschi
Palma Maurizi
Vita Ridola
Stefano Mastrangelo
Roberta Migliorati
Patrizia Bertolini
Cesare Colosimo
Riccardo Riccardi
Agostino Gemelli University Polyclinic · ITPontifícia Universidade Católica de São Paulo · BRSantobono Children's Hospital · ITUniversity Hospitals Parma Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The treatment of children with malignant glioma remains challenging. The aim of this multicenter phase I study is to establish the recommended dose (RD) of the combination therapy with temozolomide (TMZ) and oral etoposide (VP-16) in children with relapsed or refractory malignant glioma and brainstem glioma at diagnosis. A phase I trial was conducted to establish the maximum tolerated dose (MTD) of TMZ and oral VP-16. This orally administered combination was investigated by a classical 3 + 3 design. Cohorts of patients were enrolled at 4 different levels: (1) TMZ 120 mg/m(2) on days 1-5 and VP-16 50 mg/m(2) on days 1-8; (2) TMZ 150 mg/m(2) on days 1-5 and VP-16 50 mg/m(2) on days 1-8; (3) TMZ 150 mg/m(2) on days 1-5 and VP-16 50 mg/m(2) on days 1-10; (4) TMZ 150 mg/m(2) on days 1-5 and VP-16 50 mg/m(2) on days 1-12. Therapy was administered in 28-day courses. A total of 118 courses were administered to 18 patients with a median age of 11.2 years. At dose level 1, none displayed toxicity. Of the 6 patients at dose level 2, 1 patient had dose limiting toxicity (DLT). None of the 3 patients at dose level 3 had DLT. At dose level 4, grade III/IV thrombocytopenia and neutropenia were observed in 2 out of the 6 patients enrolled. Therefore, the MTD was established at dose level 3. The RD for phase II trial in children with malignant glial is TMZ 150 mg/m(2) for 5 days and VP-16 50 mg/m(2) for 10 days every 28 days.

Indexed as

Salvage TherapyAdministration, OralAdolescentAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsChildChild, PreschoolDacarbazineDrug Resistance, NeoplasmEtoposideFemaleFollow-Up StudiesGliomaHumansMaleMaximum Tolerated DoseDacarbazineEtoposideTemozolomide

Identifiers

PMID23666235
OpenAlexW2108962375

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.