Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma
- 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
- 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.
- 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
- 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