Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
José Mordoh, M.D., Ph.D.
Age
17–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Vaccination of Melanoma Patients With Dendritic Cells Loaded With Allogeneic Apoptotic-Necrotic Melanoma Cells
