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KRN7000 in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003985
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: KRN7000
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   KRN 7000   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   40
Study Start Date:   September 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003985

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

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Giuseppe Giaccone, MD, PhD     Free University Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067189, EORTC-13972, KIRIN-EORTC-13972
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003985
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
KRN 7000
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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