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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658437
• Other study ID #: CY503C1
• Secondary ID: EudraCT no. 2007
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2008
• Last updated: June 7, 2011
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2009
• Source: Cytavis Biopharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• CY-503
solution for subcutaneous injection, 350 ng twice weekly

Locations

Country	Name	City	State
Germany	Haut Tumor Zentrum Charité	Berlin
Germany	Dermatologisches Zentrum Elbe-Klinikum Buxtehude	Buxtehude
Germany	Hautklinik Linden MH Hannover	Hannover
Germany	Universitäts-Hautklinik Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Cytavis Biopharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor assessment by CT and MRT		each 8 weeks	No
Secondary	Immunological response (e.g. measurement of cytokines in serum)		each 4 weeks	No
Secondary	Assessment of quality of life using a standardized questionnaire		each 4 weeks	No