Immune Therapy of HPV-induced Cancers (NCT01462838) | Clinical Trial Compass
CompletedPhase 1/2
Immune Therapy of HPV-induced Cancers
Germany26 participantsStarted 2011-08
Plain-language summary
Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16\_37-63 in combination with MontanideĀ® ISA-51 VG so that an immune response directed against the tumor cells can be induced. The aim is to show that vaccination with P16\_37-63 is safe and can induce or enhance immune responses against p16INK4a.
Who can participate
Age range18 Years
SexALL
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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 ā„ 1.5 x 109/L Lymphocyte count ā„ 0.5 x 109/L Platelet count ā„ 100 x 109/L Serum bilirubin \< 2mg/dL
* Male or female patients ā„ 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 treatmentā¦