Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Prof. Dr. Silke Gillessen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed melanoma
Inoperable Stage III or Stage IV melanoma
Tumor expression of Melan-A and/or NY-Eso-1 by immunohistochemistry
Human leukocyte antigen (HLA)-A0201 positivity (flow cytometry and PCR)
Life expectancy more than three months
Full recovery from surgery
Karnofsky scale performance status of 70% or more (App II)
One prior chemo- or cytokine based therapy is allowed
Age \> 18 years
No uncontrolled infections
Neutrophile count \>1500/ul and thrombocytes \>100 000/ul
Creatinine \<1.5 of upper normal level
Adequate liver function with bilirubin \<2 of upper normal level, alanine aminotransferase (ALAT) and aspartate aminotransaminase (ASAT) \< 3 x upper normal level
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
before patient registration, informed consent must be given according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), and national/local regulations
You may not be if
Presently clinically significant heart disease (NYHA Class III or IV)
Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
History of immunodeficiency disease or severe autoimmune disease
Metastatic disease to the central nervous system
HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection
Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry
Concomitant treatment with steroids or antihistamine drugs. Topical or inhalational steroids are permitted
Participation in any other clinical trial involving another investigational agent within 6 weeks prior to enrollment
Pregnancy or lactation
Women of childbearing potential not using a medically acceptable means of contraception
Lack of availability of the patient for immunological and clinical follow-up assessment.
Coagulation or bleeding disorders
Rapidly progressing disease
Clareo Health | Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Patients With Inoperable Stage III and Stage IV Melanoma
