Immune Therapy of HPV-induced Cancers

NCT01462838 | Completed Phase 1 DMC

• 1 other identifier: VicOryx
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 be induced. The aim is to show that vaccination with P16\_37-63 is safe and can induce or enhance immune responses against p16INK4a.

Conditions

HPV-induced Cancers

Keywords

advanced HPV-; p16INK4a-positive; cervical; vulvar,; vaginal; penile; anal; head; neck

Outcome Measures

Primary Outcomes (1)

• Immune response

  Immune response against peptide P16\_37-63. A positive immune response is defined as positive DTH response against peptide P16\_37-63 or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of p16INK4a-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against peptide P16\_37-63.

  every 2 weeks

Secondary Outcomes (2)

• Tumor response

  every 8 weeks

• safety

  up to 8 months

Study Arms (1)

Immunization

EXPERIMENTAL

P16\_37-63 peptide plus Montanide ISA-51 VG

Biological: P16_37-63

Interventions

P16_37-63 BIOLOGICAL

100 ug per application subcutaneously, mixed with 0.3 ml Montanide ISA-51 VG; once a week for four weeks, followed by a 4 week rest period (1 cycle), up to 3 cycles

Immunization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oryx GmbH & Co. KG: lead

Study Sites (1)

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

Study Officials

• Elke Jäger, Prof. Dr.

  Krankenhaus Nordwest Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 31, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

DE (1)