MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003028
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
CHU de la Timone
🇫🇷Marseille, France
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Ludwig Boltzmann - Institute for Applied Cancer Research
🇦🇹Vienna, Austria
Institut Bergonie
🇫🇷Bordeaux, France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Henri Becquerel
🇫🇷Rouen, France
Universitats-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Institut Curie - Section Medicale
🇫🇷Paris, France
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Hopital Paul Brousse
🇫🇷Villejuif, France
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Schneider Children's Medical Center of Israel
🇮🇱Petah-Tikva, Israel
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
San Raffaele Hospital
🇮🇹Rome, Italy
Klinikum Nurnberg
🇩🇪Nuremberg (Nurnberg), Germany
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Herlev, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Centre Oscar Lambret
🇫🇷Lille, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Claudius Regaud
🇫🇷Toulouse, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Leon Berard
🇫🇷Lyon, France
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
University Hospital
🇨ðŸ‡Basel, Switzerland
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
University of Ioannina
🇬🇷Ioannina, Greece
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Kantonsspital - Saint Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Institut Jules Bordet
🇧🇪Brussels, Belgium
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Rambam Medical Center
🇮🇱Haifa, Israel
Clinique De Genolier
🇨ðŸ‡Genolier, Switzerland
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom