Phase I Clinical Trial of a Therapeutic Vaccine Composed of Autologous Dendritic Cells Loaded With Allogeneic Apoptotic Tumor Cells in Patients With Melanoma Stages IIB, IIC, III and IV
Inclusion Criteria:
- histologically confirmed cutaneous melanoma stages IIB, IIC, III or IV (AJCC)
- pts with minimal or non-detectable disease (NED) after surgery as asserted by CAT
scans. Melanoma pts with unknown primary tumor site could be included in the study
- life expectancy > 6 months
- ages:from 15 to 60 years
- performance status (ECOG) 0 or 1
- pts with stage III disease had to be previously treated with IFN-alpha, and either
finished the treatment or suspended it due to disease progression, toxicity or other
clinical reasons. Alternatively, those pts who had not started IFN-alpha within six
months after surgery could be included in this study
- a suitable venous access for the leukapheresis procedure
- laboratory eligibility criteria included: hemoglobin > 10 gr %; WBC count > 4800/mm3,
platelets > 150.000/mm3, total and direct bilirubin, serum oxalacetic transaminase
and glutamic pyruvic transaminase < 1.5 fold the upper normal value; LDH < 450 mU/ml
- absence of pregnancy, with serum βHCG determined one week before vaccination in
premenopausal women
- serum creatinine < 1.4 mg %
- no chemotherapy, radiotherapy or any biological treatments during the previous month
- no concurrent medication with corticosteroids or NSAIDs
- l no active brain metastases m- normal ECG
- all pts gave written informed consent before inclusion in the Study.
Exclusion Criteria:
- Ocular melanoma or melanoma of mucosa
- Active brain metastases
- Other previous carcinoma (with the exeption of cervical or in situ basal cells
carcinoma adequately treated)
- Pregnant or breast-feeding women
- Cardiac Arythmia, severe heart disease.
- Bacterial, mycotic or viral serious infections ( > grade 2 according to NCI common
toxicity criteria)
- HIV, B or C Hepatitis previous infection
- Primary or secondary immunodeficiencies
- Other diseases that require treatment with regular corticoids or non steroids
anti-inflammatory drugs or COX-2 inhibitors