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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00306514
First received: March 23, 2006
Last updated: September 19, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: CYT004-MelQbG10
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Blood donation or loss of > 400mL within 8 weeks prior to inclusion.
  • Hemoglobin (Hb) < 10g/dL
  • Abuse of alcohol or other recreational drugs.
  • Previous vaccination with a Melan-A peptide analogue.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306514

Locations
Germany
Dept. of Dermatology, Venerology and Allergy
Berlin, Germany, 10117
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Principal Investigator: Wolfram Sterry, MD University Hospital Charite, Berlin, D
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306514     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 01
Study First Received: March 23, 2006
Last Updated: September 19, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Cytos Biotechnology AG:
metastatic malignant melanoma of the skin

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 20, 2014