Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Histologically confirmed, unresectable, Stage IV metastatic melanoma
Failure of prior chemotherapy and / or immunotherapy based regimen
Measurable disease (based on RECIST criteria)
Males and females of at least 18 years of age
Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Life expectancy of at least 3 months
WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥100,000/mm3
Bilirubin ≤ 1.5 mg/dL (25.65 μmol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be ≤3.5 mg/dL (59.86 μmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN); hepatic alkaline phosphatase ≤ 3.0 × ULN
LDH ≤ 2.5 upper limit of normal (ULN)
Serum creatinine ≤ 1.5 mg/dL (132.60 μmol/L), proteinuria < 2.0 g/24 hr urine
Patients who have had prior treatment with adjuvant or palliative immunotherapy are eligible provided that therapy ended at least 1 month prior to randomization and all treatment-related toxicities have resolved
Patients with bone metastasis should be evaluated by the investigator and prior treatment should be finished at least 1 month prior to randomization
Prior radiotherapy (for palliative care only) is allowed provided there is measurable/evaluable disease outside of the radiation field and all radiation-related toxicities have resolved; if there is only one measurable lesion it may not have been irradiated unless subsequent progression has been documented
Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery and all surgical wounds have healed prior to randomization and at least one measurable tumor is present
All toxicities related to prior adjuvant therapy must have resolved
Written informed consent

Exclusion Criteria:

Pregnancy or nursing
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
Current or planned participation in a research protocol
Received an investigational agent within 4 weeks prior to randomization
Brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis
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 within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis requiring anticoagulant therapy
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 in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.