Status:
COMPLETED
Immune Therapy of HPV-induced Cancers
Lead Sponsor:
Oryx GmbH & Co. KG
Conditions:
HPV-induced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16\_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can b...
Detailed Description
The present study is initiated to evaluate vaccination with P16\_37-63 -peptide in patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. S...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01462838
Start Date
August 1 2011
End Date
May 1 2015
Last Update
June 23 2015
Active Locations (1)
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1
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488