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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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1997-06-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors.
Detailed Description
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OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on days 1, 8, and 15. Treatment continues every 4 weeks, or upon recovery of toxicity, whichever comes later. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for at least 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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sabarubicin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections No other nonmalignant disease that precludes study No history of alcoholism, drug addiction, or psychotic disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No prior anthracyclines or anthracenediones No other concurrent investigational 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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Emma Geertruida Elisabeth De Vries, MD, PhD
Role: STUDY_CHAIR
University Medical Center Groningen
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 Branch
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen
Herlev, , Denmark
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 Nurnberg
Nuremberg (Nurnberg), , Germany
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Kantonsspital - Saint 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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Other Identifiers
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EORTC-16970
Identifier Type: -
Identifier Source: secondary_id
EORTC-16970
Identifier Type: -
Identifier Source: org_study_id