ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma

Phase 2

Completed

• Conditions: Lung Cancer; Melanoma (Skin)

• Registration Number: NCT00003989
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or metastatic melanoma.

Detailed Description

OBJECTIVES: I. Determine the complete and partial response rates and duration of response in patients with locally advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or metastatic melanoma treated with ISIS 3521. II. Determine safety of ISIS 3521 in these patients.

OUTLINE: This is a multicenter study. Patients are stratified by disease type. Patients receive ISIS 3521 IV over 21 days followed by 7 days of rest. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (27)

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

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

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

St. Radboud University Hospital; 🇳🇱 Nijmegen, Netherlands

Inselspital, Bern; 🇨🇭 Bern, Switzerland

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

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

Kaiser Franz Josef Hospital; 🇦🇹 Vienna (Wien), Austria

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

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

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

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Leon Berard; 🇫🇷 Lyon, France

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

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

University Hospital; 🇨🇭 Basel, Switzerland

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