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MEN-10755 in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003982
  Purpose

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 patients who have solid tumors.


Condition Intervention Phase
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Drug: sabarubicin
Phase I

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Sabarubicin    Men 10755   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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 Week for 3 Consecutive Weeks, Followed by One Week's Rest

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   June 1997

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of MEN-10755 in patients with solid tumors. II. Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. III. Propose a safe dose for phase II study. IV. Study the pharmacokinetics of this drug at different dose levels in this patient population. V. Document any possible antitumor activity of this drug in this patient population.

OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on days 1, 8, and 15. Treatment continues every 4 weeks, or upon recovery of toxicity, whichever comes later. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for at least 3 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy Measurable or evaluable disease No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/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) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections No other nonmalignant disease that precludes study No history of alcoholism, drug addiction, or psychotic disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No prior anthracyclines or anthracenediones No other concurrent investigational drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003982

Locations
Austria
Innsbruck Universitaetsklinik    
      Innsbruck, Austria, A-6020
Kaiser Franz Josef Hospital    
      Vienna, Austria, A-1100
Belgium
Institut Jules Bordet    
      Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Ludwig Institute for Cancer Research-Brussels Branch    
      Brussels, Belgium, B-1200
Denmark
Herlev Hospital - University Hospital of Copenhagen    
      Herlev, Denmark, DK-2730
France
Centre Jean Perrin    
      Clermont-Ferrand, France, 63011
Centre Leon Berard    
      Lyon, France, 69373
CRLCC Nantes - Atlantique    
      Nantes-Saint Herblain, France, 44805
Institut Claudius Regaud    
      Toulouse, France, 31052
Institut Gustave Roussy    
      Villejuif, France, F-94805
Germany
Klinikum Nurnberg    
      Nuremberg (Nurnberg), Germany, D-90419
Universitaetsklinik und Strahlenklinik - Essen    
      Essen, Germany, D-45122
Netherlands
Academisch Ziekenhuis der Vrije Universiteit    
      Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen    
      Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB
Norway
Norwegian Radium Hospital    
      Oslo, Norway, N-0310
Switzerland
Inselspital, Bern    
      Bern, Switzerland, CH-3010
Kantonsspital - Saint Gallen    
      Saint Gallen, Switzerland, CH-9007
University Hospital    
      Basel, Switzerland, CH-4031
United Kingdom, England
Newcastle General Hospital    
      Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
United Kingdom, Scotland
Western General Hospital    
      Edinburgh, Scotland, United Kingdom, EH4 9NQ
Ninewells Hospital and Medical School    
      Dundee, Scotland, United Kingdom, DD1 9SY
C.R.C. Beatson Laboratories    
      Glasgow, Scotland, United Kingdom, G61 1BD

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Emma Geertruida Elisabeth De Vries, MD, PhD     University Medical Centre Groningen    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067186, EORTC-16970
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003982
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  
testicular embryonal carcinoma and yolk sac tumor  

Study placed in the following topic categories:
Neoplasms, Germ Cell and Embryonal
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2008




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