- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003989
ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma
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
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Innsbruck, Austria, A-6020
- Universitaetsklinik
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Vienna (Wien), Austria, A-1100
- Kaiser Franz Josef Hospital
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Brussels (Bruxelles), Belgium, 1000
- Institut Jules Bordet
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Brussels (Bruxelles), Belgium, B-1200
- Ludwig Institute for Cancer Research-Brussels Branch
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Herlev, Denmark, DK-2730
- Herlev Hospital - University Hospital of Copenhagen
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Lyon, France, 69373
- Centre Leon Berard
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Nantes-Saint Herblain, France, 44805
- CRLCC Nantes - Atlantique
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Toulouse, France, 31052
- Institut Claudius Regaud
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Essen, Germany, D-45122
- Universitaetsklinik und Strahlenklinik - Essen
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Nuremberg (Nurnberg), Germany, D-90419
- Klinikum Nürnberg
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Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoekhuis
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Amsterdam, Netherlands, 1007 MB
- Academisch Ziekenhuis der Vrije Universiteit
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Groningen, Netherlands, 9713 EZ
- Academisch Ziekenhuis Groningen
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Nijmegen, Netherlands, 6500 HB
- St. Radboud University Hospital
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Rotterdam, Netherlands, 3075 EA
- Rotterdam Cancer Institute
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Oslo, Norway, N-0310
- Norwegian Radium Hospital
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Basel, Switzerland, CH-4031
- University Hospital
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Bern, Switzerland, CH-3010
- Inselspital, Bern
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Saint Gallen, Switzerland, CH-9007
- Kantonsspital - Saint Gallen
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England
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Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
- Newcastle General Hospital
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Scotland
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Dundee, Scotland, United Kingdom, DD1 9SY
- Ninewells Hospital and Medical School
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Edinburgh, Scotland, United Kingdom, EH4 9NQ
- Western General Hospital
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Glasgow, Scotland, United Kingdom, G61 1BD
- C.R.C. Beatson Laboratories
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Investigators
- Study Chair: Shoshana Kaplan, MD, Universitaetsspital-Basel
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Melanoma
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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