Clinical trial NCT00003989: ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma
Official title: Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2004-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitaetsklinik
city: Vienna (Wien)
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels (Bruxelles)
country: Belgium
facility: Institut Jules Bordet
city: Brussels (Bruxelles)
country: Belgium
facility: Ludwig Institute for Cancer Research-Brussels Branch
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Herlev
country: Denmark
facility: Herlev Hospital - University Hospital of Copenhagen
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Essen
country: Germany
facility: Universitaetsklinik und Strahlenklinik - Essen
city: Nuremberg (Nurnberg)
country: Germany
facility: Klinikum Nurnberg
city: Amsterdam
country: Netherlands
facility: Academisch Ziekenhuis der Vrije Universiteit
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nijmegen
country: Netherlands
facility: St. Radboud University Hospital
city: Rotterdam
country: Netherlands
facility: Rotterdam Cancer Institute
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: Saint Gallen
country: Switzerland
facility: Kantonsspital - Saint Gallen
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: C.R.C. Beatson Laboratories
state: Scotland
Study officials:
affiliation: Universitaetsspital-Basel
name: Shoshana Kaplan, MD
role: STUDY_CHAIR
References: