CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy
Phase 2
Completed
- Conditions
- Melanoma
- Registration Number
- NCT00658437
- Lead Sponsor
- Cytavis Biopharma GmbH
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tumor assessment by CT and MRT each 8 weeks
- Secondary Outcome Measures
Name Time Method Immunological response (e.g. measurement of cytokines in serum) each 4 weeks Assessment of quality of life using a standardized questionnaire each 4 weeks
Trial Locations
- Locations (4)
Haut Tumor Zentrum Charité
🇩🇪Berlin, Germany
Dermatologisches Zentrum Elbe-Klinikum Buxtehude
🇩🇪Buxtehude, Germany
Universitäts-Hautklinik Kiel
🇩🇪Kiel, Germany
Hautklinik Linden MH Hannover
🇩🇪Hannover, Germany