MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors
NCT ID: NCT00003028
Last Updated: 2012-07-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
5 participants
INTERVENTIONAL
1997-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MEN-10755 in Treating Patients With Solid Tumors
NCT00003982
BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
NCT00004927
BMS-184476 in Treating Patients With Advanced Solid Tumors
NCT00003705
A Phase 1 Study of S-3304 in Patients With Solid Tumors
NCT00033215
SB-743921 In Patients With Solid Tumors
NCT00136513
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OUTLINE: This is an open label, nonrandomized study. Patients receive MEN-10755 as a single 15 minute intravenous infusion every 3 weeks, or upon recovery from toxicity. Doses will be escalated in decreasing rates and depending on the clinical judgement of the investigator. The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients at a given dose level. Patients will be removed from the study if cardiac toxicity, disease progression, or renal, cardiac or pulmonary decline is present.
PROJECTED ACCRUAL: At least 5 evaluable patients will be enrolled.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sabarubicin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per Dombernowsky, MD
Role: STUDY_CHAIR
Copenhagen County Herlev University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital - University Hospital of Copenhagen
Herlev, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Institut Curie - Section Medicale
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut Claudius Regaud
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Hopital Paul Brousse
Villejuif, , France
Institut Gustave Roussy
Villejuif, , France
Martin Luther Universitaet
Halle, , Germany
Universitats-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Nurnberg
Nuremberg (Nurnberg), , Germany
University of Ioannina
Ioannina, , Greece
Rambam Medical Center
Haifa, , Israel
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
San Raffaele Hospital
Rome, , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
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
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , Portugal
Hospital Universitario 12 de Octubre
Madrid, , Spain
University Hospital
Basel, , Switzerland
Ospedale San Giovanni
Bellinzona, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Clinique De Genolier
Genolier, , Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, , Switzerland
Royal Marsden NHS Trust
London, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-16969
Identifier Type: -
Identifier Source: secondary_id
EORTC-16969
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.