Evidence map›Paper›PMID 18559968›Full record

ReviewNeuro-oncology2008

Neurooncology clinical trial design for targeted therapies: lessons learned from the North American Brain Tumor Consortium.

Susan M Chang, Kathleen R Lamborn, John G Kuhn, W K Alfred Yung, Mark R Gilbert, Patrick Y Wen, Howard A Fine, Minesh P Mehta, Lisa M DeAngelis, Frank S Lieberman and 5 more

Open access · bronzeAbstract readReview
In one paragraph

Review in Neuro-oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Medical therapy of gliomas.Journal of neuro-oncology · 2014
    Review
  13. Article
  14. Article
  15. Article
  16. 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 8 institutions in 1 country.

Susan M ChangDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA 94143-0350, USA. changs@neurosurg.ucsf.edu
Kathleen R Lamborn
John G Kuhn
W K Alfred Yung
Mark R Gilbert
Patrick Y Wen
Howard A Fine
Minesh P Mehta
Lisa M DeAngelis
Frank S Lieberman
Timothy F Cloughesy
H Ian Robins
Lauren E Abrey
Michael D Prados
North American Brain Tumor Consortium
The University of Texas Health Science Center at San Antonio · USUniversity of California, San Francisco · USUniversity of California, Los Angeles · USUniversity of Pittsburgh Medical Center · USNational Cancer Institute · USNational Institutes of Health · USNeurological Surgery · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Kathrin Milbury · 1985 to 2026
$290.8M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
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
INSTITUTIONAL CTSA (UW-MADISON): CLINICAL TRIALSUL1RR025011 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$29.5M
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
Phase I/I I PK/PD Studies of Agents for CNS Malignancies (NABTC PK Center)U01CA062426 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI KUHN, JOHN G · 1994 to 2008
$1.4M
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 OF PRIMARY CNS MALIGNANCIESU01CA062421 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI MEHTA, MINESH P. · 1994 to 2008
$873k
NCATS NIH HHS UL1 TR000005NCI NIH HHS CA 105663-03NCI NIH HHS CA 16672NCI NIH HHS CA 62399NCI NIH HHS CA 62405NCI NIH HHS CA 62407-13NCI NIH HHS CA 62412NCI NIH HHS CA 62421NCI NIH HHS CA 62422NCI NIH HHS CA 62426NCI NIH HHS U01 CA062399NCRR NIH HHS 1U11RR025011NCRR NIH HHS M01-RR00056NCRR NIH HHS M01-RR00079NCRR NIH HHS M01-RR0865
6 · The paper itself

Abstract

The North American Brain Tumor Consortium (NABTC) is a multi-institutional consortium with the primary objective of evaluating novel therapeutic strategies through early phase clinical trials. The NABTC has made substantial changes to the design and methodology of its trials since its inception in 1994. These changes reflect developments in technology, new types of therapies, and advances in our understanding of tumor biology and biological markers. We identify the challenges of early clinical assessment of therapeutic agents by reviewing the clinical trial effort of the NABTC and the evolution of the protocol template used to design trials. To better prioritize effort and allocation of patient resources and funding, we propose an integrated clinical trial design for the early assessment of efficacy of targeted therapies in neurooncology. This design would mandate tissue acquisition prior to therapeutic intervention with the drug, allowing prospective evaluation of its effects. It would also include a combined phase 0/I pharmacokinetic study to determine the safety and biologically optimal dose of the agent and to verify successful modulation of the target prior to initiating a larger, phase II efficacy study.

Indexed as

Brain NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansResearch Design

Identifiers

PMID18559968
PMCPMC2666238
OpenAlexW2117058078

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.