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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003028
• Other study ID #: EORTC-16969
• Secondary ID: EORTC-16969
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: April 1997

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• sabarubicin

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann - Institute for Applied Cancer Research	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital - University Hospital of Copenhagen	Herlev
France	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	Vandoeuvre-les-Nancy
France	Hopital Paul Brousse	Villejuif
France	Institut Gustave Roussy	Villejuif
Germany	Martin Luther Universitaet	Halle Saale
Germany	Universitats-Krankenhaus Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum Nurnberg	Nuremberg (Nurnberg)
Greece	University of Ioannina	Ioannina
Israel	Rambam Medical Center	Haifa
Israel	Schneider Children's Medical Center of Israel	Petah-Tikva
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Istituto Europeo Di Oncologia	Milano
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	San Raffaele Hospital	Rome
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	University Hospital	Basel
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Inselspital, Bern	Bern
Switzerland	Clinique De Genolier	Genolier
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Royal Marsden NHS Trust	London	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Switzerland,  United Kingdom,