Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oslo University Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Accessible tumour tissue for vaccine production (extraction of tumour mRNA) i.e.subcutaneous or lymph node metastases.
Must be at least 18 years of age.
Must have histologically confirmed advanced, metastatic cutaneous melanoma no longer amenable for surgery.
Must have evidence of disease progression and measurable or evaluable metastases
Must be ambulatory with a ECOG performance score of \<2
Must have lab.values as following :
ANC \> 1.5 x 109/L; platelets \> 100 x 109/L, Hb \> 9g/dL (\> 5.6 mmol/L). Creatinine \< 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance \> 40 mL/min, Bilirubin \< 20% above the upper limit of normal, ASAT and ALAT \< 2.5 the upper limit of normal. Albumin \> 2.5 g/L.
Prior radiotherapy: A minimum of 4 weeks (8 weeks in case of extensive radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
Prior chemotherapy: A minimum 4 weeks must have elapsed between the end of the prior chemotherapy and entry into the protocol.
Signed informed consent of the patients for the treatment and follow up must be obtained and documented according to the ICH-GCP Guidelines.
You may not be if
History of prior malignancy other than melanoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervix stage 1B.
Active infection requiring antibiotic therapy.
Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
Autoimmune disease currently treated with steroids.
Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
Pregnancy or lactation.
Any reason why, in the opinion of the investigator, the patient should not participate.
Clareo Health | Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma
