CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy

Study Overview
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Brief Summary
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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).

Official Title
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A Phase II Multicenter Study to Test Progression-free and Overall Survival of CY-503 in the Treatment of Patients With Unresectable Stage IV Metastatic Melanoma After Antineoplastic Treatment Failure

Conditions
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Melanoma

Intervention / Treatment
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* Drug: CY-503


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CY-503|solution for subcutaneous injection, 350 ng twice weekly|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor assessment by CT and MRT |  | each 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response (e.g. measurement of cytokines in serum) |  | each 4 weeks | 
| Assessment of quality of life using a standardized questionnaire |  | each 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Stage IV, Phase II