- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003985
KRN7000 in Treating Patients With Solid Tumors
Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Innsbruck, Austria, A-6020
- Innsbruck Universitaetsklinik
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Vienna, Austria, A-1100
- Kaiser Franz Josef Hospital
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Brussels, Belgium, B-1200
- Ludwig Institute for Cancer Research-Brussels Branch
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Herlev, Denmark, DK-2730
- Herlev Hospital - University Hospital of Copenhagen
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Lyon, France, 69373
- Centre Leon Berard
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Nantes-Saint Herblain, France, 44805
- CRLCC Nantes - Atlantique
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Toulouse, France, 31052
- Institut Claudius Regaud
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Essen, Germany, D-45122
- Universitaetsklinik und Strahlenklinik - Essen
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Nuremberg (Nurnberg), Germany, D-90419
- Klinikum Nürnberg
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Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoekhuis
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Amsterdam, Netherlands, 1117 MB
- Academisch Ziekenhuis der Vrije Universiteit
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Groningen, Netherlands, 9713 EZ
- Academisch Ziekenhuis Groningen
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Nijmegen, Netherlands, NL-6252 HB
- University Medical Center Nijmegen
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Rotterdam, Netherlands, 3075 EA
- Rotterdam Cancer Institute
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Oslo, Norway, N-0310
- Norwegian Radium Hospital
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Basel, Switzerland, CH-4031
- University Hospital
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Bern, Switzerland, CH-3010
- Inselspital, Bern
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Saint Gallen, Switzerland, CH-9007
- Kantonsspital - Saint Gallen
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England
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Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
- Newcastle General Hospital
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Scotland
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Dundee, Scotland, United Kingdom, DD1 9SY
- Ninewells Hospital and Medical School
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Edinburgh, Scotland, United Kingdom, EH4 9NQ
- Western General Hospital
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Glasgow, Scotland, United Kingdom, G61 1BD
- C.R.C. Beatson Laboratories
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-13972
- KIRIN-EORTC-13972
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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