Bevacizumab (Avastin™), dacarbazine and interferon a-2a (Roferon-A; IFN a-2a ) combination as a first-line therapy in patients with locally advancing or metastatic melanoma

Turku University Central Hospital0 个研究点目标入组 40 人2005年4月26日

概览

暂无简介。

注册库

who.int

开始日期

2005年4月26日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Turku University Central Hospital

•1\.Histologically confirmed diagnosis of malignant melanoma either locally progressing inoperable or metastatic. Previous adjuvant therapy with interferon is allowed.
•2\.Age 18 or above
•3\.Measurable or evaluable disease in accordance with RECIST criteria
•4\.WHO performance status \=2 and normal organ function
•5\.lab values in protocol
•6\.Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
•7\.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee \[IEC]) will be obtained prior to any study specific screening procedures
•8\.Patient must be able to comply with the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Unevaluable disease
•2\.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
•3\.Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
•4\.Clinical or radiological (CT) evidence of CNS metastases
•5\.Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated Basal and squamous cell carcinoma of the skin or In\-situ carcinoma of the cervix
•6\.Serious non\-healing wound or ulcer
•7\.Evidence of bleeding diathesis or coagulopathy
•8\.Uncontrolled hypertension
•9\.Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (\= 6 months), myocardial infarction (\= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
•10\.Evidence of serious depression or psychosis, which needs continuous medication.