Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
- Histologically confirmed diagnosis of malignant melanoma.
- Previously untreated and non-resectable disease
- Measurable or evaluable tumour.
- Age ≥ 18 and ≤ 75 years.
- Performance status ECOG-WHO 0, 1 and 2 (Appendix III)
- Written informed consent (Appendix II)
- Adequate bone marrow liver, heart and renal function:
- WBC count >3.0 x 109/L and platelets count >100 x 109/L.
- ASAT, ALAT <2 x upper normal laboratory value.
- Serum creatinine <2 x upper normal laboratory value.
- Previous treatment with chemotherapy.
- Clinical signs of brain metastases.
- Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable
cardiac or coronary artery disease.
- Severe active infections such as HIV or hepatitis B or Hepatitis C.
- Medication for severe intercurrent disease which might affect immunocompetence (e.g.
immunosuppressants, systemic corticosteroids).
- Pregnancy, breast-feeding or absence of adequate contraception for fertile patients.
- Simultaneously participation in other clinical studies.
- Any reason why, in the opinion of the investigator, the patient should not