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 - CY-503 Phase II Malignant Melanoma
- Conditions
- unresectable progressive metastatic melanoma stage IV after antineoplastic treatmet failureMedDRA version: 9.1Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)
- Registration Number
- EUCTR2007-000427-17-DE
- Lead Sponsor
- CYTAVIS BioPharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?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 <1 year post-menopausal) must have a negative serum ß human chorionic gonadotropin (ßhCG) 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 (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicide, cervical cap, abstinence, or sterile sex partner) at the time the informed consent is signed (women only) or at the time of the initiation of CY-503 (men only), and both women and men must agree to continue using such precautions while receiving CY-503 and for 30 days after the final dose of CY-503.
?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 ULN.
?Serum creatinine = 1.5 mg/dL (132.60 µmol/L), proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein.
?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.
?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 obtained from the patient prior to receipt of any study medication or beginning study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
?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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.Assessment of median time of progressive free survival.<br>2.Assessment of time to second objective progression.<br>3.Assessment of overall survival.<br>;Secondary Objective: 1.Assessment of disease control rate (CR + PR + SD)<br>2.Safetey<br>3.Quality of life<br><br>;Primary end point(s): 1. Assessment of median time of progression free survival<br>2. Assessment of time to second objective progression<br>3. Assessment of overall survival<br>
- Secondary Outcome Measures
Name Time Method