Evidence map›Paper›PMID 21547395›Full record

ArticleJournal of neuro-oncology2011

Phase I and pharmacokinetic study of COL-3 in patients with recurrent high-grade gliomas.

Michelle A Rudek, Pamela New, Tom Mikkelsen, Surasak Phuphanich, Jane B Alavi, Louis B Nabors, Steven Piantadosi, Joy D Fisher, Stuart A Grossman

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004147 (A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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.

NCT00004147 phase1 / phase2completednot on this map

A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma

TypeinterventionalSponsorNew Approaches to Brain Tumor Therapy ConsortiumRan2000 to 2006ConditionsBrain and Central Nervous System TumorsArmsincyclinide
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Proteases Regulate Cancer Stem Cell Properties and Remodel Their Microenvironment.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2021
    Review
  5. Hypoxia-dependent drivers of melanoma progression.Journal of experimental & clinical cancer research : CR · 2021
    Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Matrix metalloproteinases in the brain and blood-brain barrier: Versatile breakers and makers.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2016
    Review
  11. Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Article
  12. Article
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 6 institutions in 1 country.

Michelle A RudekDepartment of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231, USA.
Pamela New
Tom Mikkelsen
Surasak Phuphanich
Jane B Alavi
Louis B Nabors
Steven Piantadosi
Joy D Fisher
Stuart A Grossman
Sidney Kimmel Comprehensive Cancer Center · USCedars-Sinai Medical Center · USBaylor College of Medicine · USHenry Ford Hospital · USHospital of the University of Pennsylvania · USUniversity of Alabama · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
Adult Brain Tumor Consortium (ABTC)U01CA137443 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A, PRADOS, MICHAEL D · 2009 to 2013
$11.0M
NEW APPROACHES TO BRAIN TUMOR THERAPY CNS CONSORTIUMU01CA062475 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 1994 to 2008
$5.6M
NCI NIH HHS P30 CA006973NCI NIH HHS U01 CA062475NCI NIH HHS U01 CA137443NCI NIH HHS U01-CA62475
6 · The paper itself

Abstract

COL-3 is a chemically modified tetracycline that targets multiple aspects of matrix metalloproteinase regulation. This phase I clinical trial was conducted to determine the maximum tolerated dose (MTD) of COL-3 in adults with recurrent high-grade glioma, to describe the effects of enzyme-inducing antiseizure drugs (EIADs) on its pharmacokinetics, and to obtain preliminary evidence of activity. Adults with recurrent high-grade glioma were stratified by EIAD use. COL-3 was given orally daily without interruption until disease progression or treatment-related dose-limiting toxicity (DLT). Three patients in each EIAD group were evaluated at each dose level beginning with 25 mg/m(2)/day and escalated by 25 mg/m(2)/day. Toxicity, response, and pharmacokinetics were assessed. Thirty-three patients were evaluated. The MTD was 75 mg/m(2)/day in the -EIAD patients while one was not determined in +EIAD patients. The common toxicities observed were anemia, ataxia, diarrhea, hypokalemia, CNS hemorrhage, and myalgia. One partial response was observed. -EIAD patients tended to have a higher steady-state trough concentration that was apparent only at the 100 mg/m(2)/day dose level (P = 0.01). This study suggests that: (a) EIAD use does affect the pharmacokinetics of COL-3 at higher doses; and (b) there was not enough suggestion of single-agent activity to warrant further study in recurrent high-grade gliomas.

Indexed as

AdultAgedAnticonvulsantsBrain NeoplasmsFemaleFollow-Up StudiesGliomaHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm GradingNeoplasm Recurrence, LocalPrognosisTetracyclinesTissue DistributionAnticonvulsantstetracycline CMT-3Tetracyclines

Identifiers

PMID21547395
PMCPMC3197967
OpenAlexW2070695744

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.