Randomized, Comparative Phase II/III Study Between Treatment With CSF470 Vaccine (Allogeneic, Irradiated) Plus BCG and MOLGRAMOSTIN (rhGM-CSF) as Adjuvants and Interferon-alfa 2b (IFN-ALPHA), in Stages IIB, IIC and III Post Surgery Cutaneous Melanoma Patients
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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