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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:
NCT00306553
First received: March 23, 2006
Last updated: September 18, 2006
Last verified: September 2006
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

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.
  • 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.
  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: NCT00306553

Locations
Switzerland
Dept. of Dermatology, USZ
Zuerich, Switzerland, 8091
Dept. of Oncology, USZ
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Principal Investigator: Alexander Knuth, MD Dept. of Oncology, Univerity Hospital Zuerich, CH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306553     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 03
Study First Received: March 23, 2006
Last Updated: September 18, 2006
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 27, 2014