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MEN-10755 in Treating Patients With Solid Tumors

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00003982
Collaborator
(none)
30
Enrollment
27
Locations
1.1
Patients Per Site

Study Details

Study Description

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 patients who have solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Primary Purpose:
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
Study Start Date :
Jun 1, 1997

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

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

    Sponsors and Collaborators

    • European Organisation for Research and Treatment of Cancer - EORTC

    Investigators

    • Study Chair: Emma Geertruida Elisabeth De Vries, MD, PhD, University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Organisation for Research and Treatment of Cancer - EORTC
    ClinicalTrials.gov Identifier:
    NCT00003982
    Other Study ID Numbers:
    • EORTC-16970
    • EORTC-16970
    First Posted:
    May 25, 2004
    Last Update Posted:
    Jul 11, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
    unspecified adult solid tumor, protocol specific
    testicular embryonal carcinoma and yolk sac tumor
    Additional relevant MeSH terms:
    Neoplasms
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of Jul 11, 2012