Evidence map›Paper›PMID 19430790›Full record

ArticleCancer chemotherapy and pharmacology2009

Pharmacokinetics of temozolomide administered in combination with O6-benzylguanine in children and adolescents with refractory solid tumors.

Holly J Meany, Katherine E Warren, Elizabeth Fox, Diane E Cole, Alberta A Aikin, Frank M Balis

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

Article in Cancer chemotherapy and pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00020150 (Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT00020150 phase1completednot on this map

Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2000ConditionsBrain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney CancerArmsO6-benzylguanine, temozolomide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. 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

6 authors at 1 institution in 1 country.

Holly J MeanyPediatric Oncology Branch, National Cancer Institute, 10 Center Drive, Bldg. 10 CRC/Rm. 1-5750, Bethesda, MD 20892, USA. hmeany@cnmc.org
Katherine E Warren
Elizabeth Fox
Diane E Cole
Alberta A Aikin
Frank M Balis
National Cancer Institute · US

Funding

Clinical Pharmacology of Anticancer DrugsZIABC011080 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BALIS, FRANK · 2009 to 2009
$1.3M
Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Z01BC010583 · NCI · BASIC SCIENCES · PI WARREN, KATHERINE E · 2005 to 2007
$110k
Intramural NIH HHS Z01 BC010583
6 · The paper itself

Abstract

purposeTemozolomide pharmacokinetics were evaluated in children receiving concurrent O(6)-benzylguanine (O(6)BG), which enhanced the hematological toxicity of temozolomide.

methodsTemozolomide was administered orally, daily for 5 days starting at 28 mg/m(2) per day with escalations to 40, 55, 75 and 100 mg/m(2) per day with O(6)BG intravenously daily for 5 days at doses of 60, 90 or 120 mg/m(2) per day. Plasma samples were drawn over 48 h after the day 5 dose. Temozolomide was quantified with a validated HPLC/tandem mass spectroscopic assay.

resultsTemozolomide was rapidly absorbed (mean T (max), 2.1 h). The mean apparent clearance (CL/F) (96 mL/min/m(2)) was similar to the CL/F for temozolomide alone and was not age- or gender-dependent. There was minimal inter-patient variability.

conclusionsThe enhanced hematologic toxicity resulting from combining O(6)BG with temozolomide does not appear to be the result of a pharmacokinetic interaction between the agents.

Indexed as

AdolescentAge FactorsAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolChromatography, High Pressure LiquidDacarbazineDose-Response Relationship, DrugDrug InteractionsFemaleGuanineHematologic DiseasesHumansMaleNeoplasmsSex FactorsDacarbazineGuanineO(6)-benzylguanineTemozolomide

Identifiers

PMID19430790
PMCPMC6301000
OpenAlexW2068637098

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.