Evidence map›Paper›PMID 18725460›Full record

Trial reportNeuro-oncology2008

Phase II preradiation R115777 (tipifarnib) in newly diagnosed GBM with residual enhancing disease.

Robert Lustig, Tom Mikkelsen, Glenn Lesser, Stuart Grossman, Xiaobu Ye, Serena Desideri, Joy Fisher, John Wright, New Approaches to Brain Tumor Therapy CNS Consortium

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

Trial report in Neuro-oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. The use of radiosensitizing agents in the therapy of glioblastoma multiforme-a comprehensive review.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022
    Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Targeted therapy in gliomas.Current oncology reports · 2014
    Review
  14. Review
  15. RRP22: a novel neural tumor suppressor for astrocytoma.Medical oncology (Northwood, London, England) · 2012
    Article
  16. Article
  17. Review
  18. Article
  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 5 institutions in 1 country.

Robert LustigHospital of the University of Pennsylvania, Philadelphia, PA, USA.
Tom Mikkelsen
Glenn Lesser
Stuart Grossman
Xiaobu Ye
Serena Desideri
Joy Fisher
John Wright
New Approaches to Brain Tumor Therapy CNS Consortium
Henry Ford Health System · USNational Cancer Institute · USHospital of the University of Pennsylvania · USSidney Kimmel Comprehensive Cancer Center · USWake Forest University · US

Funding

NEW APPROACHES TO BRAIN TUMOR THERAPY CNS CONSORTIUMU01CA062475 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 1994 to 2008
$5.6M
Phamacokinetics Center for the NABTT CNS ConsortiumU01CA105689 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SUPKO, JEFFREY G · 2004 to 2008
$934k
NCI NIH HHS P30-CA0516NCI NIH HHS U01 CA062475NCI NIH HHS U01 CA105689NCI NIH HHS U01-CA105689NCI NIH HHS U01-CA62475
6 · The paper itself

Abstract

Glioblastoma multiforme (GBM) is a lethal primary malignant brain tumor in adults. R115777 (tipifarnib) is an oral agent with antiproliferative effects, being a potent and selective inhibitor of farnesyltransferase. This multicenter, open-label phase II study was designed to evaluate the efficacy and safety of R115777 given after surgery and prior to radiation in patients with newly diagnosed and residual enhancing GBM. Following surgery, an MRI confirmed the presence of residual enhancing tumor. Patients on enzyme-inducing antiseizure drugs (EIASDs) received 600 mg twice per day, and those not on EIASDs received 300 mg twice per day. One to three monthly cycles of R115777 were administered, and radiation was initiated with progression or after three cycles. A cycle consisted of 3 weeks of continuous R115777 followed by a 1-week rest. MRI was done monthly. The primary end point was overall survival; secondary end points were tumor response rate and toxicity. A total of 28 confirmed GBM patients entered the study; 15 patients (54%) were on EIASDs. The overall median time of survival was 7.7 months. There were no tumor responses. Eight patients (29%) had stable disease as the best response. The study was stopped early due to progression of the disease in 12 patients (48%). A total of 24 patients (85%) were off study before the planned treatment schedule for radiation therapy. R115777 administered prior to radiation therapy in patients with newly diagnosed GBM and residual enhancing disease did not result in any measurable responses or improvement in survival. R115777 administered prior to radiation therapy is not recommended for patients with newly diagnosed GBM.

Indexed as

AdultAgedAged, 80 and overAnticonvulsantsAntineoplastic AgentsBrain NeoplasmsCombined Modality TherapyFemaleGlioblastomaHumansKaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedNeoplasm, ResidualNeurosurgical ProceduresAnticonvulsantsAntineoplastic AgentsQuinolonestipifarnib

Identifiers

PMID18725460
PMCPMC2718997
OpenAlexW2108667604

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.