National Agency for Scientific and Technological Promotion, Argentina
Fundacion Cancer FUCA
National Council of Scientific and Technical Research, Argentina
Instituto Nacional del Cáncer, Argentina
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
histologically confirmed cutaneous melanoma stages IIB, IIC or III (AJCC)
patients 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
performance status (ECOG) 0 or 1
Time post surgery not more than 4 months
no chemotherapy, radiotherapy or any biological treatments prior to this study.
patients must have CATscans of brain, thorax, abdomen and pelvis in the 60 previous days to trial enrolling
To have laboratory studies (no more than 15 days before entering the study)
laboratory eligibility criteria include: hematocrit: ≥35 (hemoglobin \> 10,5 gr %); WBC count \> 3500/mm3, platelets \> 100.000/mm3, total and direct bilirubin, serum oxalacetic transaminase and glutamic pyruvic transaminase \< 1.5 fold the upper normal value; LDH ≤ 450 mU/ml
negative serology for HIV, anti-HCV and HBsAg
serum creatinine \< 2.0 mg %
all patients must give written informed consent before inclusion in the Study.
You may not be if
Pregnant or breast-feeding women
Diabetes (Type I or II)
Antecedents of psychiatric diseases
Evidence of active infections
Antecedents of viral or autoimmune hepatitis
Previous autoimmune diseases
Morbid Obesity, defined as CMI (Corporal mass index)\>37 kg/m2 in women and \>40 kg/m2 in men.
Other diseases that require treatment with regular corticoids or non steroids anti-inflammatory drugs
Clareo Health | Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients
