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	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific testicular embryonal carcinoma and yolk sac tumor	Drug: MEN-10755	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Emma Geertruida Elisabeth De Vries,  Study Chair,  EORTC Early Clinical Studies Group   

Study ID Numbers:  CDR0000067186; EORTC-16970
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003982
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08