Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

This study is ongoing, but not recruiting participants.

First Received: April 1, 2008 Last Updated: April 24, 2009 History of Changes

Sponsored by:	Cytos Biotechnology AG
Information provided by:	Cytos Biotechnology AG
ClinicalTrials.gov Identifier:	NCT00651703

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 alone or in combination with different adjuvants.

Condition	Intervention	Phase
Malignant Melanoma	Biological: CYT004-MelQbG10 + Montanide Biological: CYT004-MelQbG10 + Montanide + Imiquimod Biological: CYT004-MelQbG10 + Imiquimod Biological: CYT004-MelQbG10 intra nodal injection	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: S 26308

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: CYT004-MelQbG10 + Montanide
2: Experimental	Biological: CYT004-MelQbG10 + Montanide + Imiquimod
3: Experimental	Biological: CYT004-MelQbG10 + Imiquimod
4: Experimental	Biological: CYT004-MelQbG10 intra nodal injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological confirmed Stage III or IV malignant melanoma
HLA-A*0201 haplotype
Expected survival of at least 9 months
Willing and able to comply with all trial requirements (e.g. diaries, CTs)
Given written informed consent
Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception

Exclusion Criteria:

Any contraindication to any study related test or assessment
Current or planned use of contraindicated concomitant medication
Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
Infection with HIV, HBV or HCV
Pregnancy or lactation or females planning to become pregnant during the study
Abuse of alcohol or other drugs
Use of investigational drug within 30 days before enrolment
Previous participation in a clinical trial with a Qb-based Cytos vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651703

Locations

Switzerland
Dermatologische Klinik, UniversitätsSpital Zürich
Zurich, Switzerland, CH-8091
Switzerland, VD
Ludwig Institute for Cancer Research; CHUV
Lausanne, VD, Switzerland, CH-1005

Sponsors and Collaborators

Cytos Biotechnology AG

More Information

No publications provided

Responsible Party:	Cytos Biotechnology AG ( Head Clinical Development )
Study ID Numbers:	CYT004-MelQbG10 04
Study First Received:	April 1, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00651703 History of Changes
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Neuroectodermal Tumors
Immunologic Factors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Interferons
Adjuvants, Immunologic

Neuroepithelioma
Imiquimod
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Imiquimod

Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 11, 2009