Immune Therapy of HPV-induced Cancers

Inclusion Criteria:

* Histologically confirmed, advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer cancers under progression, regression or with stable disease after standard therapy (and still incurable) or after refusal of standard therapy or with contraindications for standard treatment
* HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue
* Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue.
* Expected survival of at least six months.
* Full recovery from surgery, chemo therapy or radiation therapy.
* ECOG performance status 0, 1 or 2.
* The following laboratory results:

Neutrophil count ≥ 1.5 x 109/L Lymphocyte count ≥ 0.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin \< 2mg/dL

* Male or female patients ≥ 18 years old
* Patient´s written informed consent for participation in the trial

Exclusion Criteria:

* Prior treatment with P16\_37-63 peptide
* Clinically significant heart disease (NYHA Class III or IV).
* Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders.
* History of immunodeficiency disease or autoimmune disease.
* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
* HBV, HCV or HIV positivity.
* Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
* Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
* Participation in any other clinical trial involving another investigational agent within 4 weeks.
* Pregnancy or lactation.
* Women of childbearing potential who are not using a medically acceptable means of contraception.
* Psychiatric or addictive disorders that may compromise the ability to give informed consent.
* Lack of availability of a patient for immunological and clinical follow-up assessment.
* Brain metastases (symptomatic and non-symptomatic)