Clinical Trial Details
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NCT01973322 : Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized "Proof-of-principle" Phase II Study
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

1. Signed Written Informed Consent: patients must be willing and able to give written
informed consent, that have to be given before starting of screening procedure.

2. Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by
the "Product Specification File".

3. Patients must have histologically or cytologically confirmed malignant unresectable
stage III or stage IV melanoma;

4. Patients must have a minimum of two lesions, one of which must be measurable,(i.e.
that can be accurately measured in two perpendicular dimensions, with at least 1
diameter >20 mm and the other dimension >10 mm with conventional techniques or at
least 10 x 10 mm with spiral CT scan).

5. Patients carrying BRAF mutation-positive melanoma must have received previous
Vemurafenib, unless they are not eligible or refuse the treatment.

6. Patients treated with previous first line therapy must have received Ipilimumab,
unless they are not eligible or refuse the treatment.

7. Pretreated brain metastases which have been clinically stable for at least 6 months
and not requiring corticosteroids are allowed;

8. ECOG performance status 0-1;

9. Negative screening tests for HIV, HBV HCV and syphilis not older than 30 days before
performing any of the GMP-regulated activities required (leukapheresis, collection of
tumor biopsies to be used for tumor lysate/homogenate preparation);

10. Prior lines of chemotherapy, immunotherapy or biological therapy (e.g. inhibitors of
B-Raf or c-Kit, Ipilimumab, etc.) for advanced disease are allowed (patients must
have lasted prior treatments at least 4 weeks before the first vaccine dose);

11. Men and women aged 18-70 years.

12. Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up 8 weeks after the
study, in order to minimize the risk of pregnancy;

13. Patients must have normal organ and marrow function as defined below:

- leukocytes >1,500/microL

- absolute neutrophil count >1,000/microL

- platelets >80,000/microL

- total bilirubin within 2 x ULN


- creatinine ? 2 mg/dl

Exclusion Criteria:

1. Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood
testing must be performed within 30 days before any GMP-regulated activity
(leukapheresis and collection of tumor biopsies to be used for tumor
lysate/homogenate preparation).

2. Patients with unresectable or metastatic melanoma BRAF V600 mutation-positive
eligible to Vemurafenib cannot be enrolled in first line, unless they refuse this

3. Patients eligible for Ipilimumab treatment, cannot be enrolled unless they refuse
this treatment.

4. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier.

5. Participation in another clinical trial with any investigational agents within 30
days prior to study screening.

6. Patients with known progressing and/or symptomatic brain metastases.

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements (on physician's judgment).

8. Other known malignant neoplastic diseases in the patient's medical history with a
disease-free interval of less than 3 years (except for previously treated basal cell
carcinoma and in situ carcinoma of the uterine cervix);

9. Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g.
severe anemia, piastrinopenia, oral anticoagulant therapy).
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