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

June 7, 2011 updated by: Cytavis Biopharma GmbH

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

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).

Study Overview

Status

Completed

Conditions

Melanoma

Intervention / Treatment

Drug: CY-503

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, D-10117
    - Haut Tumor Zentrum Charité
  - Buxtehude, Germany, D-21603
    - Dermatologisches Zentrum Elbe-Klinikum Buxtehude
  - Hannover, Germany, D-30449
    - Hautklinik Linden MH Hannover
  - Kiel, Germany, D-24105
    - Universitäts-Hautklinik Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor assessment by CT and MRT Time Frame: each 8 weeks	each 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytavis Biopharma GmbH

Investigators

Principal Investigator: Peter Mohr, MD, Elbe Klinikum Buxtehude, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria