NCT00003979

Brief 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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
9 countries

28 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

First QC Date

November 1, 1999

Last Update Submit

July 10, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

CHS 828DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (28)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, B-1000, Belgium

Location

Ludwig Institute for Cancer Research

Brussels, B-1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Herlev Hospital - University Hospital of Copenhagen

Copenhagen, DK-2730, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, 90340, Germany

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

C.R.C. Beatson Laboratories

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 15763645RESULT

MeSH Terms

Interventions

N-(6-chlorophenoxyhexyl)-N''-cyano-N''-4-pyridylguanidine

Study Officials

  • Thomas Cerny, MD

    Cantonal Hospital of St. Gallen

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1999

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

GB(4)NO(1)CH(3)AU(2)FR(6)DE(2)NL(5)DK(1)BE(4)