Evidence map›Paper›PMID 18661102›Full record

Trial reportJournal of neuro-oncology2008

A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme.

Camilo E Fadul, Linda S Kingman, Louise P Meyer, Bernard F Cole, Clifford J Eskey, C Harker Rhodes, David W Roberts, Herbert B Newton, J Marc Pipas

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

Trial report in Journal of neuro-oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00039468 (A Phase II Study Of Thalidomide And CPT-11), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT00039468 phase2completednot on this map

A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme

TypeinterventionalSponsorDartmouth-Hitchcock Medical CenterRan2002 to 2008Enrolled26ConditionsBrain and Central Nervous System TumorsArmsirinotecan hydrochloride, thalidomide
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Efficacy of thalidomide for the treatment of amyotrophic lateral sclerosis: a phase II open label clinical trial.Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases
    Trial
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. GEINOFOTE: efficacy and safety of fotemustine in patients with high-grade recurrent gliomas and poor performance status.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016
    Article
  15. Lessons from anti-vascular endothelial growth factor and anti-vascular endothelial growth factor receptor trials in patients with glioblastoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Article
  16. Review
  17. Targeted therapy in gliomas.Current oncology reports · 2014
    Review
  18. Review
  19. Article
  20. Review
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 at 2 institutions in 1 country.

Camilo E FadulDepartment of Medicine, Section of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center Drive, One Medical Center Drive, Lebanon, NH 03756, USA. camilo.e.fadul@hitchcock.org
Linda S Kingman
Louise P Meyer
Bernard F Cole
Clifford J Eskey
C Harker Rhodes
David W Roberts
Herbert B Newton
J Marc Pipas
Dartmouth–Hitchcock Medical Center · USCenter for Neuro-Oncology · US

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108
6 · The paper itself

Abstract

purposeIrinotecan is a cytotoxic agent with activity against gliomas. Thalidomide, an antiangiogenic agent, may play a role in the treatment of glioblastoma multiforme (GBM). To evaluate the combination of thalidomide and irinotecan, we conducted a phase II trial in adults with newly-diagnosed or recurrent GBM. PATIENTS AND

methodsThalidomide was given at a dose of 100 mg/day, followed by dose escalation every 2 weeks by 100 mg/day to a target of 400 mg/day. Irinotecan was administered on day 1 of each 3 week cycle. Irinotecan dose was 700 mg/m(2) for patients taking enzyme-inducing anticonvulsants and 350 mg/m(2) for all others. The primary endpoint was tumor response, assessed by MRI. Secondary endpoints were toxicity, progression-free survival, and overall survival.

resultsTwenty-six patients with a median age of 55 years were enrolled, with fourteen evaluable for the primary outcome, although all patients were included for secondary endpoints. One patient (7%) exhibited a partial response after twelve cycles, and eleven patients (79%) had stable disease. The intention to treat group with recurrent disease included 16 patients who had a 6-month PFS of 19% (95% CI: 4-46%) and with newly-diagnosed disease included 10 patients who had a 6-month PFS of 40% (95% CI: 12-74%). Gastrointestinal (GI) toxicity was mild, but six patients (23%) experienced a venous thromboembolic complication. Two patients had Grade 4 treatment-related serious adverse events that required hospitalization. There were no treatment-related deaths.

conclusionThe combination of irinotecan and thalidomide has limited activity against GBM. Mild GI toxicity was observed, but venous thromboembolic complications were common.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCentral Nervous System NeoplasmsDisease ProgressionFemaleGlioblastomaHumansImmunosuppressive AgentsIrinotecanMaleMiddle AgedSurvival AnalysisThalidomideCamptothecinImmunosuppressive AgentsIrinotecanThalidomide

Identifiers

PMID18661102
PMCPMC3885231
OpenAlexW2036562916

What OpenQuestion holds

Textmetadata
LicenceTDM
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.