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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (27)

Universitaetsklinik

🇦🇹

Innsbruck, Austria

Kaiser Franz Josef Hospital

🇦🇹

Vienna (Wien), Austria

Institut Jules Bordet

🇧🇪

Brussels (Bruxelles), Belgium

Ludwig Institute for Cancer Research-Brussels Branch

🇧🇪

Brussels (Bruxelles), Belgium

Universitair Ziekenhuis Antwerpen

🇧🇪

Edegem, Belgium

U.Z. Gasthuisberg

🇧🇪

Leuven, 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

Scroll for more (17 remaining)
Universitaetsklinik
🇦🇹Innsbruck, Austria

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