KRN7000 in Treating Patients With Solid Tumors

Phase 1

Withdrawn

• Conditions: Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003985
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-24
• Study First Posted: 2004-05-25
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (27)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Ludwig Institute for Cancer Research-Brussels Branch; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

University Hospital; 🇨🇭 Basel, Switzerland

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom

C.R.C. Beatson Laboratories; 🇬🇧 Glasgow, Scotland, United Kingdom

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Herlev, Denmark

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Centre Leon Berard; 🇫🇷 Lyon, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Western General Hospital; 🇬🇧 Edinburgh, Scotland, United Kingdom

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

Ninewells Hospital and Medical School; 🇬🇧 Dundee, Scotland, United Kingdom