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

July 10, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Universitaetsklinik
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Brussels (Bruxelles), Belgium, B-1200
        • Ludwig Institute for Cancer Research-Brussels Branch
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Herlev, Denmark, DK-2730
        • Herlev Hospital - University Hospital of Copenhagen
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69373
        • Centre Leon Berard
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinik und Strahlenklinik - Essen
      • Nuremberg (Nurnberg), Germany, D-90419
        • Klinikum Nürnberg
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Amsterdam, Netherlands, 1007 MB
        • Academisch Ziekenhuis der Vrije Universiteit
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, 6500 HB
        • St. Radboud University Hospital
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Saint Gallen, Switzerland, CH-9007
        • Kantonsspital - Saint Gallen
  • United Kingdom
    • England
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 9NQ
        • Western General Hospital
      • Glasgow, Scotland, United Kingdom, G61 1BD
        • C.R.C. Beatson Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically proven melanoma that is unresectable and regionally metastatic, or widely disseminated OR Histologically or cytologically proven non-small cell lung cancer (NSCLC) that is locally advanced, unresectable, or metastatic Stage IIIA, IIIB, or IV Evidence of disease progression prior to study At least 1 bidimensionally measurable lesion The following are NOT considered measurable: previously irradiated lesions, ascites, pleural effusion, bone metastases, brain metastases, leptomeningeal disease, or an abdominal mass that can be palpated but not measured Melanoma patients whose only manifestation of disease is 1 of the following are NOT eligible: Lymphedema Pleural effusion Ascites CNS metastases Bone marrow infiltration Osteoblastic bone lesions

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Shoshana Kaplan, MD, Universitaetsspital-Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 26, 2004

First Posted (ESTIMATE)

August 27, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16977
  • ISIS-EORTC-16977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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