MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors

NCT00003028 | Completed Phase 1

• 1 other identifier: EORTC-16969
• Study Type: interventional
• Target: 5
• Locations: 14 countries
• Sites: 49

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 MEN-10755 in treating adults who have recurrent or refractory solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

sabarubicin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: WHO 0-2 Life Expectancy: At least 3 months Hematopoietic: ANC at least 2,000/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) (unless related to liver metastases, then no greater than 5 times ULN) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF greater than 50% (measured by MUGA scan) Other: Not pregnant or nursing Effective contraceptive method must be used during study No active bacterial infections No other nonmaliganant diseases No history of alcoholism or drug abuse No psychosis PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study Concurrent use of growth factors is allowed in cases of febrile neutropenia (prophylactic use not allowed) Chemotherapy: No prior chemotherapy within 4 weeks of study No prior nitrosoureas, mitomycin, or high dose carboplatin within 6 weeks of study Endocrine therapy: No concurrent corticosteroids (unless approved by clinical investigator) Radiotherapy: No prior radiotherapy within 4 weeks of study No prior extensive radiotherapy within 6 weeks of study Surgery: Not specified Other: No prior experimental therapy No prior anthracyclines or anthracenediones

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (49)

Ludwig Boltzmann - Institute for Applied Cancer Research

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital - University Hospital of Copenhagen

Herlev, DK-2730, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Universitats-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Klinikum Nurnberg

Nuremberg (Nurnberg), D-90419, Germany

Location

University of Ioannina

Ioannina, GR-45110, Greece

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

San Raffaele Hospital

Rome, 00144, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1117 MB, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Kantonsspital - Saint Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Newcastle General Hospital

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

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Interventions

sabarubicin

Study Officials

• Per Dombernowsky, MD

  Copenhagen County Herlev University Hospital

  STUDY CHAIR

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: June 16, 2004
• Study Start: April 1, 1997
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

GB (4); DK (2); AU (1); IL (2); FR (14); PT (1); DE (4); BE (3); GR (1); NL (5); CH (5); IT (5); NO (1); ES (1)