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Home > "M" Clinical Trials Conditions > MEN-10755 in Treating Patients With Solid Tumors  MEN-10755 in Treating Patients With Solid Tumors
MEN-10755 in Treating Patients With Solid Tumors
For Condition: testicular embryonal carcinoma and yolk sac tumor,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EmmaElisabeth De Vries, Study Chair, EORTC Early Clinical Studies Group
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , B-1200
Belgium
Inselspital, Bern
Bern, , CH-3010
Switzerland
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Centre Leon Berard
Lyon, , 69373
France
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Institut Gustave Roussy
Villejuif, , F-94805
France
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Institut Claudius Regaud
Toulouse, , 31052
France
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
University Hospital
Basel, , CH-4031
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067186; EORTC-16970
Study Start Date: June 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003982
Other Testicular Embryonal Carcinoma And Yolk Sac Tumor Studies:
1. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
2. SU6668 in Treating Patients With Advanced Solid Tumors
3. Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
4. Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
5. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
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MEN-10755 in Treating Patients With Solid Tumors
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