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

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: sabarubicin

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
• Enrollment (Anticipated): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Study Chair: Per Dombernowsky, MD, Copenhagen County Herlev University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 1997

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: June 15, 2004
• First Posted (Estimate): June 16, 2004

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 29, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: EORTC-16969