Evidence map›Paper›PMID 23099651›Full record

Trial reportNeuro-oncology2012

Phase I/II study of sorafenib in combination with temsirolimus for recurrent glioblastoma or gliosarcoma: North American Brain Tumor Consortium study 05-02.

Eudocia Q Lee, John Kuhn, Kathleen R Lamborn, Lauren Abrey, Lisa M DeAngelis, Frank Lieberman, H Ian Robins, Susan M Chang, W K Alfred Yung, Jan Drappatz and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 3% 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

67 citing papers in PubMed, 2 syntheses or guidelines pooled it, 110 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Biomaterial-basedCancer pathogenesis and therapy · 2023
    Review
  13. Review
  14. Review
  15. Therapeutic Options in Neuro-Oncology.International journal of molecular sciences · 2022
    Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review

7 more citing papers are in PubMed but not listed here.

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

19 authors at 9 institutions in 1 country.

Eudocia Q LeeCenter for Neuro-Oncology, Dana Farber/Brigham and Women’s Cancer Center, Boston, Massachusetts 02215, USA.
John Kuhn
Kathleen R Lamborn
Lauren Abrey
Lisa M DeAngelis
Frank Lieberman
H Ian Robins
Susan M Chang
W K Alfred Yung
Jan Drappatz
Minesh P Mehta
Victor A Levin
Kenneth Aldape
Janet E Dancey
John J Wright
Michael D Prados
Timothy F Cloughesy
Mark R Gilbert
Patrick Y Wen
Center for Neuro-Oncology · USDana-Farber Brigham Cancer Center · USNational Cancer Institute · USNorthwestern University · USUniversity of California, Los Angeles · USMemorial Sloan Kettering Cancer Center · USUniversity of California, San Francisco · USUniversity of Pittsburgh · USUniversity of Wisconsin–Madison · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NABTC - Foreign AccrualU01CA062399 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PRADOS, MICHAEL D · 1994 to 2008
$4.7M
NCATS NIH HHS UL1 TR000005NCATS NIH HHS UL1 TR000124NCI NIH HHS P30 CA014520NCI NIH HHS P30 CA016672NCI NIH HHS U01 CA062399NCRR NIH HHS UL1 RR024148NCRR NIH HHS UL1 RR024153
6 · The paper itself

Abstract

The activity of single-agent targeted molecular therapies in glioblastoma has been limited to date. The North American Brain Tumor Consortium examined the safety, pharmacokinetics, and efficacy of combination therapy with sorafenib, a small molecule inhibitor of Raf, vascular endothelial growth factor receptor 2, and platelet-derived growth factor receptor-β, and temsirolimus (CCI-779), an inhibitor of mammalian target of rapamycin. This was a phase I/II study. The phase I component used a standard 3 × 3 dose escalation scheme to determine the safety and tolerability of this combination therapy. The phase II component used a 2-stage design; the primary endpoint was 6-month progression-free survival (PFS6) rate. Thirteen patients enrolled in the phase I component. The maximum tolerated dosage (MTD) for combination therapy was sorafenib 800 mg daily and temsirolimus 25 mg once weekly. At the MTD, grade 3 thrombocytopenia was the dose-limiting toxicity. Eighteen patients were treated in the phase II component. At interim analysis, the study was terminated and did not proceed to the second stage. No patients remained progression free at 6 months. Median PFS was 8 weeks. The toxicity of this combination therapy resulted in a maximum tolerated dose of temsirolimus that was only one-tenth of the single-agent dose. Minimal activity in recurrent glioblastoma multiforme was seen at the MTD of the 2 combined agents.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDisease-Free SurvivalFemaleGlioblastomaHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNiacinamidePhenylurea CompoundsSirolimusSorafenibYoung AdultNiacinamidePhenylurea CompoundsSirolimusSorafenibtemsirolimus

Identifiers

PMID23099651
PMCPMC3499017
OpenAlexW2138218580

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.