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KRN7000 in Treating Patients With Solid Tumors

Primary Purpose

Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KRN7000
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring non-small cell lung cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innsbruck Universitaetsklinik
  • Kaiser Franz Josef Hospital
  • Institut Jules Bordet
  • Ludwig Institute for Cancer Research-Brussels Branch
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Herlev Hospital - University Hospital of Copenhagen
  • Centre Jean Perrin
  • Centre Leon Berard
  • CRLCC Nantes - Atlantique
  • Institut Claudius Regaud
  • Institut Gustave Roussy
  • Universitaetsklinik und Strahlenklinik - Essen
  • Klinikum Nurnberg
  • Antoni van Leeuwenhoekhuis
  • Academisch Ziekenhuis der Vrije Universiteit
  • Academisch Ziekenhuis Groningen
  • University Medical Center Nijmegen
  • Rotterdam Cancer Institute
  • Norwegian Radium Hospital
  • University Hospital
  • Inselspital, Bern
  • Kantonsspital - Saint Gallen
  • Newcastle General Hospital
  • Ninewells Hospital and Medical School
  • Western General Hospital
  • C.R.C. Beatson Laboratories

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 10, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003985
Brief Title
KRN7000 in Treating Patients With Solid Tumors
Official Title
Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
non-small cell lung cancer, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
KRN7000

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giaccone, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Innsbruck Universitaetsklinik
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Kaiser Franz Josef Hospital
City
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Ludwig Institute for Cancer Research-Brussels Branch
City
Brussels
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Herlev Hospital - University Hospital of Copenhagen
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum Nurnberg
City
Nuremberg (Nurnberg)
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1117 MB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6252 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 9NQ
Country
United Kingdom
Facility Name
C.R.C. Beatson Laboratories
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G61 1BD
Country
United Kingdom

12. IPD Sharing Statement

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KRN7000 in Treating Patients With Solid Tumors

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