CD 20 in Stage IV Melanoma Patients
- Conditions
- Patients suffering from early stage melanoma have a good chance of recovery whereas the 5-year survival rate of patients with metastasized melanomas (stage III and stage IV) is less than 10% for this aggressive tumor.Detailed understanding of molecular mechanism leading to melanoma development and progression would be a great benefit.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023277-19-AT
- Lead Sponsor
- Med. Univ. Wien, Univ. Klinik für Dermatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
•Signed informed consent prior to any study-mandated procedure.
•Metastatic non-ocular melanoma (clinical stage IV)
•measurable disease with more than one metastatic lesion
•One of these metastases must be resectable prior to anti-CD20 therapy. ECOG performance status of 0-2.
•As soon as BRAF inhibitors are standard of care, we will include only patients with tumors containing BRAF wildtype.
Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with active brain metastasis and Ig-deficiency will be excluded.
Subjects meeting any of the following criteria must not be enrolled in an ofatumumab study:
•Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
•Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
•Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
•Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
•History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
•HIV positive
•Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
•Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
•Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
•Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
•Screening laboratory values:
platelets <70 x 109/L
leukocytes <1.5 x 109/L
creatinine >2.0 times upper normal limit
total bilirubin >1.5 times upper normal limit
ALT >2.5 times upper normal limit
alkaline phosphatase >2.5 times upper normal limit
•Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening.
•Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
•Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the overall tumor response rate; ;Secondary Objective: The secondary objectives are the assessment of progression-free survival, overall survival, duration of overall response, evaluation of cell biological responses as well as the safety outcome according to NCI-CTC and –CTCAE v.4.02;Primary end point(s): assessment of overall tumor response rate (according to RECIST criteria) <br><br>;Timepoint(s) of evaluation of this end point: week 4, 8 16 and 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •assessment of progression-free survival (PFS), defined as the time from first day of treatment to the first documentation of disease progression or death, whichever occurs first. <br>•overall survival (OS), duration of disease control<br>•safety outcome according to NCI-CTC and -CTCAE v.4.03 criteria <br>•evaluation of cell biological responses<br>;Timepoint(s) of evaluation of this end point: week 4, 8 16 and 24