Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
1999-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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CHS 828
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Thomas Cerny, MD
Role: STUDY_CHAIR
Cantonal Hospital of St. Gallen
Locations
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Innsbruck Universitaetsklinik
Innsbruck, , Austria
Kaiser Franz Josef Hospital
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Ludwig Institute for Cancer Research
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinik und Strahlenklinik - Essen
Essen, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-16985
Identifier Type: -
Identifier Source: secondary_id
EORTC-16985
Identifier Type: -
Identifier Source: org_study_id