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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003028
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: sabarubicin Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of MEN-10755 in patients with recurrent or refractory adult solid tumors. II. Determine the qualitative and quantitative toxic effects of MEN-10755 and study the predictability, duration, intensity, onset, reversibility, and dose relationship of the toxic effects in these patients. III. Propose a safe dose for phase II study. IV. Assess the pharmacokinetics of MEN-10755 at different dose levels in these patients. V. Document any possible antitumor activity of MEN-10755.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Primary Purpose: Treatment
Official Title: Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks
Study Start Date : April 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003028

  Hide Study Locations
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, Austria, A-1100
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Copenhagen, Denmark, 2100
Herlev Hospital - University Hospital of Copenhagen
Herlev, Denmark, DK-2730
Institut Bergonie
Bordeaux, France, 33076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
CHU de la Timone
Marseille, France, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Institut Curie - Section Medicale
Paris, France, 75248
Centre Eugene Marquis
Rennes, France, 35062
Centre Henri Becquerel
Rouen, France, 76038
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Martin Luther Universitaet
Halle Saale, Germany, DOH-0-6112
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinikum Nurnberg
Nuremberg (Nurnberg), Germany, D-90419
University of Ioannina
Ioannina, Greece, GR-45110
Rambam Medical Center
Haifa, Israel, 31096
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
San Raffaele Hospital
Rome, Italy, 00144
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6252 HB
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Norwegian Radium Hospital
Oslo, Norway, N-0310
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
University Hospital
Basel, Switzerland, CH-4031
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital, Bern
Bern, Switzerland, CH-3010
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Kantonsspital - Saint Gallen
Saint Gallen, Switzerland, CH-9007
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Per Dombernowsky, MD Copenhagen County Herlev University Hospital

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003028     History of Changes
Other Study ID Numbers: EORTC-16969
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unspecified adult solid tumor, protocol specific