CClinicalTrials.gg
WithdrawnNCT00003979Updated Jul 11, 2012

CHS 828 in Treating Patients With Solid Tumors

A Phase 1 interventional study of CHS 828 in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Withdrawn at 28 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-11.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine a safe dose of this regimen for phase II evaluation.
  • Determine the pharmacokinetic profile of this regimen in these patients.
  • Determine any antitumor activity in these patients.

OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Browse trials for

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

Browse Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor not amenable to standard therapy
  • No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 4,000/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)

Renal:

  • Creatinine no greater than 1.4 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active bacterial infection
  • No other nonmalignant disease
  • No alcoholism, drug addiction, or psychiatric disorders
  • Able to take oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
  • No concurrent radiotherapy (except palliative radiotherapy)

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs
  • No other concurrent antitumor drugs
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
0 participants (actual)

Interventions

  • DrugCHS 828
06

Study locations

28 sites
  • Innsbruck Universitaetsklinik
    Innsbruck, A-6020, Austria
  • Kaiser Franz Josef Hospital
    Vienna, A-1100, Austria
  • Institut Jules Bordet
    Brussels, B-1000, Belgium
  • Ludwig Institute for Cancer Research
    Brussels, B-1200, Belgium
  • Universitair Ziekenhuis Antwerpen
    Edegem, B-2650, Belgium
  • U.Z. Gasthuisberg
    Leuven, B-3000, Belgium
  • Herlev Hospital - University Hospital of Copenhagen
    Copenhagen, DK-2730, Denmark
  • Institut Bergonie
    Bordeaux, 33076, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Centre Leon Berard
    Lyon, 69373, France
  • CRLCC Nantes - Atlantique
    Nantes-Saint Herblain, 44805, France
  • Institut Claudius Regaud
    Toulouse, 31052, France
  • Institut Gustave Roussy
    Villejuif, F-94805, France
  • Universitaetsklinik und Strahlenklinik - Essen
    Essen, D-45122, Germany
  • Klinikum Nuernberg - Klinikum Nord
    Nuremberg, 90340, Germany
  • Vrije Universiteit Medisch Centrum
    Amsterdam, 1001HV, Netherlands
  • Antoni van Leeuwenhoekhuis
    Amsterdam, 1066 CX, Netherlands
  • Academisch Ziekenhuis Groningen
    Groningen, 9700 RB, Netherlands
  • University Medical Center Nijmegen
    Nijmegen, NL-6500 HB, Netherlands
  • Erasmus Medical Center
    Rotterdam, 3075 EA, Netherlands
  • Norwegian Radium Hospital
    Oslo, N-0310, Norway
  • University Hospital
    Basel, CH-4031, Switzerland
  • Inselspital, Bern
    Bern, CH-3010, Switzerland
  • Kantonsspital - St. Gallen
    St. Gallen, CH-9007, Switzerland
  • Newcastle General Hospital
    Newcastle Upon Tyne, England NE4 6BE, United Kingdom
  • Ninewells Hospital and Medical School
    Dundee, Scotland DD1 9SY, United Kingdom
  • Western General Hospital
    Edinburgh, Scotland EH4 2XU, United Kingdom
  • C.R.C. Beatson Laboratories
    Glasgow, Scotland G61 1BD, United Kingdom
07

References and documents

Publications

  • Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023. PubMed 15763645 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003979
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 1999
Last update
Jul 11, 2012

Study contacts

Thomas Cerny, MD
study chair · Cantonal Hospital of St. Gallen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion