Lung CancerPhase 1NCT00003985
KRN7000 in Treating Patients With Solid Tumors
A Phase 1 study testing KRN7000 in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- KRN7000
- How many people
- 0 participants
- Where
- 27 sitesin 9 countries
- Study dates
- Sep 1998to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
France5 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Leon Berard
Lyon, 69373
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, F-94805
Netherlands5 sites
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1117 MB
Academisch Ziekenhuis Groningen
Groningen, 9713 EZ
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
Rotterdam Cancer Institute
Rotterdam, 3075 EA
Belgium4 sites
Institut Jules Bordet
Brussels, 1000
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, B-1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
United Kingdom4 sites
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Switzerland3 sites
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
Austria2 sites
Innsbruck Universitaetsklinik
Innsbruck, A-6020
Kaiser Franz Josef Hospital
Vienna, A-1100
Germany2 sites
Universitaetsklinik und Strahlenklinik - Essen
Essen, D-45122
Klinikum Nurnberg
Nuremberg (Nurnberg), D-90419
Denmark1 site
Herlev Hospital - University Hospital of Copenhagen
Herlev, DK-2730
About this study
Official title: 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.
Read the 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.
- Being tested
- KRN7000
- Keywords
- non-small cell lung cancer, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRN7000Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2004 (estimated)
- Study startSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Giaccone, MD, PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003985
- Sponsor's protocol ID
- EORTC-13972
- Other IDs
- EORTC-13972, KIRIN-EORTC-13972
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 1999
- Last updated
- 11 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule
- ClinicalTrials.gov ID
- NCT00003985
- Acronym / sponsor ID
- EORTC-13972
- Keywords
- non-small cell lung cancer, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Sep 1998
- First posted
- 25 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRN7000 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Giaccone, MD, PhD study chair
Universitair Ziekenhuis Brussel
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KRN7000 in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Netherlands, Belgium, United Kingdom, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.