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AzTrials

Lung CancerPhase 2NCT00003989

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

A Phase 2 study testing ISIS 3521 in people with Lung Cancer and Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Melanoma (Skin)
What is being tested?
ISIS 3521
How many people
50 participants
Where
27 sitesin 9 countries
Study dates
Jun 1998to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

27 sites in 9 countries.

27 sites in 9 countries

France5 sites
  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard

    Lyon, 69373

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Netherlands5 sites
  • Academisch Ziekenhuis der Vrije Universiteit

    Amsterdam, 1007 MB

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

  • St. Radboud University Hospital

    Nijmegen, 6500 HB

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

Other trials in Netherlands

Belgium4 sites
  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Ludwig Institute for Cancer Research-Brussels Branch

    Brussels (Bruxelles), B-1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

United Kingdom4 sites
  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Western General Hospital

    Edinburgh, Scotland, EH4 9NQ

  • C.R.C. Beatson Laboratories

    Glasgow, Scotland, G61 1BD

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

Other trials in United Kingdom

Switzerland3 sites
  • University Hospital

    Basel, CH-4031

  • Inselspital, Bern

    Bern, CH-3010

  • Kantonsspital - Saint Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Austria2 sites
  • Universitaetsklinik

    Innsbruck, A-6020

  • Kaiser Franz Josef Hospital

    Vienna (Wien), A-1100

Other trials in Austria

Germany2 sites
  • Universitaetsklinik und Strahlenklinik - Essen

    Essen, D-45122

  • Klinikum Nurnberg

    Nuremberg (Nurnberg), D-90419

Other trials in Germany

Denmark1 site
  • Herlev Hospital - University Hospital of Copenhagen

    Herlev, DK-2730

Other trials in Denmark

Norway1 site
  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
ISIS 3521
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
Medical subject headings
Lung Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISIS 3521Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2004 (estimated)
  2. Study startJun 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003989
Sponsor's protocol ID
EORTC-16977
Other IDs
EORTC-16977, ISIS-EORTC-16977
Status last verified
Jul 2012
First submitted
1 Nov 1999
Last updated
11 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISIS 3521 in people with Lung Cancer and Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France, Netherlands, Belgium, United Kingdom, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.

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