Evidence map›Paper›PMID 17031561›Full record

Trial reportJournal of neuro-oncology2007

A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme.

Morris D Groves, Vinay K Puduvalli, Susan M Chang, Charles A Conrad, Mark R Gilbert, Ivo W Tremont-Lukats, Ta-Jen Liu, Pamela Peterson, David Schiff, Timothy F Cloughesy and 8 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006358 (Phase II Evaluation of Temozolomide), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT00006358 phase2completednot on this map

Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2000 to 2006Enrolled44ConditionsBrain and Central Nervous System TumorsArmstemozolomide, thalidomide
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
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  10. Review
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  18. Article
  19. Targeted therapy in gliomas.Current oncology reports · 2014
    Review
  20. Blood-based biomarkers for malignant gliomas.Journal of neuro-oncology · 2013
    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

18 authors at 7 institutions in 1 country.

Morris D GrovesDepartment of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, 1400 Holcombe, 431, Houston, TX, 77030, USA. mgroves@mdanderson.org
Vinay K Puduvalli
Susan M Chang
Charles A Conrad
Mark R Gilbert
Ivo W Tremont-Lukats
Ta-Jen Liu
Pamela Peterson
David Schiff
Timothy F Cloughesy
Patrick Y Wen
Harry Greenberg
Lauren E Abrey
Lisa M DeAngelis
Kenneth R Hess
Kathleen R Lamborn
Michael D Prados
W K Alfred Yung
The University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · USMemorial Sloan Kettering Cancer Center · USDana-Farber Brigham Cancer Center · USPittsburg State University · USUniversity of California, Los Angeles · USUniversity of Michigan–Ann Arbor · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
ZDV &3TC NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFECTED INFANTS &M01RR000865 · NCRR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI WASHINGTON, ARNOLD E. · 1985 to 2011
$43.4M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RUBENFIRE, MELVYN · 1985 to 2007
$40.8M
WITHIN SUBJ VARIABILITY IN MEASUREMENTS DRUG METABOL ENZYMES IN HLTY SUBJM01RR000056 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LEVINE, ARTHUR S · 1985 to 2006
$29.2M
ZD1839 FOR MALIGNANT ASTROCYTOMA OR GLIOBLASTOMA AND MENINGIOMAM01RR000079 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$26.0M
NABTC - Foreign AccrualU01CA062399 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PRADOS, MICHAEL D · 1994 to 2008
$4.7M
THERAPEUTIC STUDIES OF PRIMARY CNS MALIGNANCIESU01CA062422 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHANG, SUSAN M · 1994 to 2008
$1.3M
THERAPIES OF PRIMARY CNS MALIGNANCIESU01CA062407 · NCI · DANA-FARBER CANCER INSTITUTE · PI WEN, PATRICK Y · 1994 to 2008
$1.2M
NABTC - M.D. Anderson Clinical CenterU01CA062412 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI GILBERT, MARK R. · 1994 to 2008
$1.1M
THERAPEUTIC STUDIES--PRIMARY CNS MALIGNANCIESU01CA062405 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LIEBERMAN, FRANK SCOTT · 1994 to 2008
$682k
NCI NIH HHS CA16672NCI NIH HHS CA62399NCI NIH HHS CA62412NCI NIH HHS CA62422NCI NIH HHS U01CA62405NCI NIH HHS U01CA62407NCRR NIH HHS M01-RR00042NCRR NIH HHS M01-RR00056NCRR NIH HHS M01-RR00079NCRR NIH HHS M01-RR0865
6 · The paper itself

Abstract

backgroundLaboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM).

objectivesTo determine 6-month progression-free survival (6PFS) and toxicity of temozolomide plus thalidomide in adults with recurrent GBM. PATIENTS AND

methodsEligible patients had recurrent GBM after surgery, radiotherapy, and/or adjuvant chemotherapy. Temozolomide was given at 150-200 mg/m(2)/day on days 1-5 of each 28-day cycle. Thalidomide was given orally at 400 mg at bedtime (days 1-28) and increased to 1,200 mg as tolerated. Patients were evaluated with magnetic resonance imaging scans every 56 days. The study was designed to detect an increase of the historical 6PFS for GBM from 10 to 30%.

resultsForty-four patients were enrolled, 43 were evaluable for efficacy and safety. The study population included 15 women, 29 men; median age was 53 years (range 32-84); median Karnofsky performance status was 80% (range 60-100%). Thirty-six (82%) patients were chemotherapy-naïve. There were 57 reports of toxicity of grade 3 or greater. Non-fatal grade 3-4 granulocytopenia occurred in 15 patients (34%). The objective response rate was 7%. The estimated probability of being progression-free at 6 months with this therapy is 24% [95% confidence interval (C.I.) 12-38%]. The median time to progression is 15 weeks (95% C.I. 10-20 weeks). There was no observed correlation between serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and IL-8 and the 6PFS outcome.

conclusionThis drug combination was reasonably safe, but with little indication of improvement compared to temozolomide alone.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDacarbazineDisease-Free SurvivalEnzyme-Linked Immunosorbent AssayFemaleGlioblastomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalNorth AmericaSurvival AnalysisDacarbazineTemozolomideThalidomide

Identifiers

PMID17031561
OpenAlexW2159378961

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.