ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||July 10, 2012|
|Start Date ICMJE||June 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003989 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma|
|Official Title ICMJE||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.
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 ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Biological: ISIS 3521|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||50|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Netherlands, United Kingdom, France, Denmark, Switzerland, Belgium, Austria, Germany, Norway|
|NCT Number ICMJE||NCT00003989|
|Other Study ID Numbers ICMJE||EORTC-16977, EORTC-16977, ISIS-EORTC-16977|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||European Organisation for Research and Treatment of Cancer - EORTC|
|Study Sponsor ICMJE||European Organisation for Research and Treatment of Cancer - EORTC|
|Collaborators ICMJE||Not Provided|
|Information Provided By||European Organisation for Research and Treatment of Cancer - EORTC|
|Verification Date||July 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP