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

NCT00306514 | Completed Phase 1

• 1 other identifier: CYT004-MelQbG10 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.

Conditions

Melanoma

Keywords

metastatic malignant melanoma of the skin

Interventions

CYT004-MelQbG10 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent
• Able and willing to complete all protocol requirements
• Age: 18 years and older
• Histologically confirmed stage III or IV melanoma
• HLA-A\*0201 haplotype
• Expected survival of at least 6 months
• ECOG performance status of 0 or 1
• At least one and no more than 2 previous systemic therapies for metastatic melanoma
• Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
• Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
• Adequate organ and bone marrow functions
• All adverse events (AEs) from 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.

You may not qualify if:

• Pregnant or nursing
• Use of an investigational drug within 30 days before enrollment
• Known or suspected brain metastases
• Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
• Major surgery within 4 weeks prior to enrollment.
• 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, or neurological disorders.
• Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
• Active autoimmune diseases or severe allergies.
• Known type 1 allergy.
• 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.
• Hemoglobin (Hb) \< 10g/dL
• Abuse of alcohol or other recreational drugs.
• Previous vaccination with a Melan-A peptide analogue.

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

Study Sites (1)

Dept. of Dermatology, Venerology and Allergy

Berlin, State of Berlin, 10117, Germany

Location

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

• Wolfram Sterry, MD

  University Hospital Charite, Berlin, D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 24, 2006
• Last Updated: September 20, 2007

Record last verified: 2007-09

Locations

DE (1)