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

NCT00658437 | Completed Phase 2

• 2 other identifiers: CY503C1EudraCT no. 2007-000427-17
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

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).

Conditions

Melanoma

Keywords

Melanoma, Stage IV, Phase II

Outcome Measures

Primary Outcomes (1)

• Tumor assessment by CT and MRT

  each 8 weeks

Secondary Outcomes (2)

• Immunological response (e.g. measurement of cytokines in serum)

  each 4 weeks

• Assessment of quality of life using a standardized questionnaire

  each 4 weeks

Interventions

CY-503 DRUG

solution for subcutaneous injection, 350 ng twice weekly

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytavis Biopharma GmbH: lead

Study Sites (4)

Haut Tumor Zentrum Charité

Berlin, D-10117, Germany

Location

Dermatologisches Zentrum Elbe-Klinikum Buxtehude

Buxtehude, D-21603, Germany

Location

Hautklinik Linden MH Hannover

Hanover, D-30449, Germany

Location

Universitäts-Hautklinik Kiel

Kiel, D-24105, Germany

Location

Related Publications (1)

• Trefzer U, Gutzmer R, Wilhelm T, Schenck F, Kahler KC, Jacobi V, Witthohn K, Lentzen H, Mohr P. Treatment of unresectable stage IV metastatic melanoma with aviscumine after anti-neoplastic treatment failure: a phase II, multi-centre study. J Immunother Cancer. 2014 Aug 19;2:27. doi: 10.1186/s40425-014-0027-z. eCollection 2014.

  PMID: 25324973 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Mohr, MD

  Elbe Klinikum Buxtehude, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2009-08

Locations

DE (4)