cy503 for the treatment of malignant melanoma stage iv after failure of prior therapy

Conditions: Melanoma

Summary: the trial is designed as a phase ii evaluation of the effect of cy-503 on progression free survival (pfs) in patients with stage iv malignant melanoma after failure of prior therapy. the aim of the study is at least a rate of 25% (pfs \>/= 3 months).


Eligibility 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.

Keywords: melanoma, stage iv, phase ii