Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Malignant Melanoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306553
• Other study ID #: CYT004-MelQbG10 03
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2006
• Last updated: September 18, 2006

Study information

• Verified date: September 2006
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to provide written informed consent.

• 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:

• Pregnant or nursing.

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Biological:
• CYT004-MelQbG10

Locations

Country	Name	City	State
Switzerland	Dept. of Dermatology, USZ	Zuerich
Switzerland	Dept. of Oncology, USZ	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland,