Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Active

18 and over

Pharmaceutical / Industry

CYT004-MelQbG10 04
NCT00651703

Trial Description

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 alone or in combination with different adjuvants.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Cytos Biotechnology AG

Philipp Mueller		Ph: ++41-44-733 Ext.47 47
		Email: info@cytos.com

Trial Sites

Switzerland

Lausanne

Ludwig Institute for Cancer Research at Hopital Orthopedique

Mueller

Email: info@cytos.com

Zurich

Dermatologische Klinik, UniversitätsSpital Zürich

Mueller

Email: info@cytos.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00651703
Information obtained from ClinicalTrials.gov on August 28, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.