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

NCT ID: NCT00003989

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30

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.

Conditions

Lung Cancer; Melanoma (Skin)

Keywords

recurrent non-small cell lung cancer; stage III melanoma; stage IV melanoma; recurrent melanoma; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

ISIS 3521

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No abnormal clotting tests Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Urinary protein less than 0.3 g/dL Cardiovascular: No superior vena cava obstruction in NSCLC unless successfully treated at least 2 months prior to study Other: No underlying disease state associated with active bleeding No prior or concurrent malignancies at other sites except adequately treated cone biopsied carcinoma in situ of the cervix uteri or basal cell or squamous cell skin cancer No nonmalignant systemic disease making patient poor risk for study No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (including interferon or interleukin-2) for melanoma patients No other concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for melanoma patients except adjuvant or local chemotherapy (extracorporeal circulation) At least 4 weeks since prior adjuvant or local chemotherapy if presence of measurable lesions outside the treated limb (6 months if no presence of measurable lesions outside the treated limb) No prior chemotherapy for NSCLC except platinum compounds used as radiosensitizer At least 4 weeks since prior platinum compounds No other concurrent anticancer chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Concurrent radiotherapy allowed for bone pain or other reasons No irradiation of all evaluable lesions Surgery: See Disease Characteristics Other: At least 4 weeks since other prior investigational drugs No other concurrent investigational drugs No concurrent anticoagulants except heparin used to prevent occlusion of IV lines during week(s) off treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shoshana Kaplan, MD

Role: STUDY_CHAIR

Universitaetsspital-Basel

Locations

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

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

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

St. Radboud University Hospital

Nijmegen, , Netherlands

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Norwegian Radium Hospital

Oslo, , Norway

University Hospital

Basel, , Switzerland

Inselspital, Bern

Bern, , Switzerland

Kantonsspital - Saint Gallen

Sankt Gallen, , Switzerland

Newcastle General Hospital

Newcastle upon Tyne, England, United Kingdom

Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Western General Hospital

Edinburgh, Scotland, United Kingdom

C.R.C. Beatson Laboratories

Glasgow, Scotland, United Kingdom

Countries

Austria; Belgium; Denmark; France; Germany; Netherlands; Norway; Switzerland; United Kingdom

Other Identifiers

EORTC-16977

Identifier Type: -

Identifier Source: secondary_id

ISIS-EORTC-16977

Identifier Type: -

Identifier Source: secondary_id

EORTC-16977

Identifier Type: -

Identifier Source: org_study_id