Evidence map›Paper›PMID 18314417›Full record

Trial reportNeuro-oncology2008

Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme.

Vinay K Puduvalli, Pierre Giglio, Morris D Groves, Kenneth R Hess, Mark R Gilbert, Srikanth Mahankali, Edward F Jackson, Victor A Levin, Charles A Conrad, Sigmund H Hsu and 5 more

Open access · bronzeAbstract readClinical Trial, Phase II
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 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 5% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Self-assembled 20-nm (64)Cu-micelles enhance accumulation in rat glioblastoma.Journal of controlled release : official journal of the Controlled Release Society · 2015
    Article
  13. Targeting the VEGF and PDGF signaling pathway in glioblastoma treatment.International journal of clinical and experimental pathology · 2015
    Article
  14. Review
  15. Targeted therapy in gliomas.Current oncology reports · 2014
    Review
  16. Article
  17. 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

15 authors at 1 institution in 1 country.

Vinay K PuduvalliDepartment of Neuro-Oncology, University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. vpuduval@mdanderson.org
Pierre Giglio
Morris D Groves
Kenneth R Hess
Mark R Gilbert
Srikanth Mahankali
Edward F Jackson
Victor A Levin
Charles A Conrad
Sigmund H Hsu
Howard Colman
John F de Groot
Melesa G Ritterhouse
Sandra E Ictech
W K Alfred Yung
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS CA 16672NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

This phase II study aimed at determining the efficacy and safety of irinotecan combined with thalidomide in adults with recurrent glioblastoma multiforme (GBM) not taking enzyme-inducing anticonvulsants (EIACs). Adult patients (> or =18 years) with recurrent GBM with up to three relapses following surgery and radiation therapy were eligible for this trial. The primary end point was rate of progression-free survival at 6 months (PFS-6); secondary end points were response rate, overall survival, and toxicity. Patients were treated in 6-week cycles with 125 mg/m(2) irinotecan weekly for 4 weeks followed by 2 weeks off treatment and 100 mg of thalidomide daily increased as tolerated to 400 mg/day. Of 32 evaluable patients, 8 (25%) were alive and progression free at 6 months. The median PFS was 13 weeks. One patient experienced a complete response, one a partial response, and 19 stable disease. Median overall survival time from entry into the study was 36 weeks, and the 1-year survival rate was 34%. Adverse events (grade 3 or 4) included diarrhea, abdominal cramps, lymphopenia, neutropenia, and fatigue. Two of the four deaths that occurred were possibly due to treatment-related toxicity. The combination of irinotecan, a cytotoxic agent, and thalidomide, an antiangiogenic agent, shows promising activity against recurrent GBM in patients not receiving EIACs and warrants further study. The results also provide support for similar strategies using combination therapies with newer targeted antiangiogenic agents to generate effective therapies against malignant gliomas.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCamptothecinDisease-Free SurvivalFemaleGlioblastomaHumansIrinotecanKaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedNeoplasm Recurrence, LocalThalidomideCamptothecinIrinotecanThalidomide

Identifiers

PMID18314417
PMCPMC2613824
OpenAlexW2169369050

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.