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Home > "K" Clinical Trials Conditions > KRN7000 in Treating Patients With Solid Tumors  KRN7000 in Treating Patients With Solid Tumors
KRN7000 in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific,Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): EORTC Biological Therapeutics Development Study Group ,
Synopsis: RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: I. Determine the safety profile and maximum tolerated dose of KRN7000 in patients with solid tumors. II. Assess the biological and immunological parameters that would suggest the optimal biologically active dose of KRN7000 in these patients. III. Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients. IV. Measure any antitumor activity in these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive KRN7000 by slow intravenous injection on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of KRN7000 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven solid tumor that is refractory to conventional treatment or for which no curative or standard palliative treatment exists - No brain involvement or leptomeningeal disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 months since prior immunotherapy; No concurrent cytokines - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose chemotherapy) - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy); No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent investigational or antitumor drugs --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG/WHO 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3; Lymphocyte count at least 600/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; AST and ALT no greater than 2.5 times upper limit of normal; No liver cirrhosis; Hepatitis B surface antigen negative - Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No New York Heart Association class III or IV heart disease - Immunologic: No immunodeficiency; No autoimmune disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active infection; No nonmalignant disease incompatible with study; No prior alcoholism, drug addiction, or psychotic disorders unless suitable for adequate follow up; No cerebroside metabolite abnormalities (e.g., Gaucher's disease); HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiuseppeGiaccone, Study Chair, EORTC Biological Therapeutics Development Study Group
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Centre Leon Berard
Lyon, , 69373
France
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Institut Jules Bordet
Brussels, , 1000
Belgium
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , B-1200
Belgium
Institut Claudius Regaud
Toulouse, , 31052
France
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
University Hospital
Basel, , CH-4031
Switzerland
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Institut Gustave Roussy
Villejuif, , F-94805
France
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Additional Information:
Study ID Numbers: CDR0000067189; EORTC-13972,KIRIN-EORTC-13972
Study Start Date: September 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003985
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KRN7000 in Treating Patients With Solid Tumors
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