Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
NCT ID: NCT00306553
Last Updated: 2006-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CYT004-MelQbG10
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able and willing to complete all protocol requirements.
* Age: 18 years and older.
* Histological confirmed stage III or IV melanoma.
* At least one confirmed detectable target lesion
* HLA-A\*0201 haplotype
* Expected survival of at least 6 months.
* Full recovery from surgery.
* Able to undergo either CT scan or MRI scan for tumor assessment.
* Wash-out period of 4 weeks after chemotherapy
* All AEs form prior anticancer therapy have resolved to ≤ Grade 1.
* Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
* Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.
Exclusion Criteria
* Use of an investigational drug within 30 days before enrolment.
* Known or suspected brain metastases.
* Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
* Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders
* Serum tests positive for HIV, HBV, HCV.
* Active autoimmune diseases or severe allergies.
* Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
* Abuse of alcohol or other recreational drugs.
* Previous vaccination with a Melan-A analog peptide.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cytos Biotechnology AG
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexander Knuth, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Oncology, Univerity Hospital Zuerich, CH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. of Dermatology, USZ
Zurich, Canton of Zurich, Switzerland
Dept. of Oncology, USZ
Zurich, Canton of Zurich, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CYT004-MelQbG10 03
Identifier Type: -
Identifier Source: org_study_id