unresectable progressive metastatic melanoma stage IV after antineoplastic treatmet failure MedDRA version: 9.1 Level: LLT Classification code 10027152 Term: Melanoma of skin (malignant)
Conditions
Interventions
Product Name: CY-503
Product Code: CY-503
Pharmaceutical Form: Injection*
INN or Proposed INN: Aviscumine
CAS Number: 223577-45-5
Current Sponsor code: CY-503
Other descriptive name: rViscumin
Concent
Sponsors
CYTAVIS BioPharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically confirmed, unresectable, Stage IV metastatic melanoma (based on AJCC staging). ? Failure of one prior DTIC-based chemotherapy regimen. ? Measurable disease (based on RECIST criteria [19] defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques (may include surface measurements or conventional computed tomography) or as = 10 mm with spiral computed tomography (CT) scan. ? Males and females of at least 18 years of age at the time of randomization. ? Women of reproductive potential (defined as being =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Pregnancy or nursing. ? Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer. ? Current or planned participation (from the day of randomization through 30 days after the last dose of CY-503) in a research protocol in which an investigational agent or therapy may be administered. ? Received an investigational agent within 4 weeks prior to randomization. ? Brain metastases or primary brain tumors, bone metastases, symptomatic pleural effusion or ascites requiring paracentesis; the absence of brain metastases must be confirmed by MRI or contrast CT scanning prior to enrolment, whether or not neurological symptoms are present. ? Ocular melanoma. ? History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer; ? Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin). ? Any current evidence of hematemesis, melena, hematochezia, or gross hematuria. ? Elective surgery planned during the study period through 30 days after the last dose of CY-503. ? History of hypersensitivity to previously administered mistletoe. ? Prior therapy with mistletoe. ? History of primary immunodeficiency. ? Known human immunodeficiency virus (HIV) or known active viral hepatic infections. ? Prior treatment with CY-503 ? A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Assessment of median time of progressive free survival. 2. Assessment of time to second objective progression. 3. Assessment of overall survival. ;Secondary Objective: 1. Assessment of disease control rate (CR + PR + SD) 2. Safetey 3. Quality of life ;Primary end point(s): 1. Assessment of median time of progression free survival 2. Assessment of time to second objective progression 3. Assessment of overall survival | — |
Countries
Germany
Outcome results
None listed