Immune Therapy of HPV-induced Cancers
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/IIa Study of Immunization With a p16INK4a Peptide Combined With MONTANIDE ISA-51 VG in Patients With Advanced HPV-associated Cancers|
- Immune response [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]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.
- Tumor response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]assessed by CT or MRI scans according to RECIST
- safety [ Time Frame: up to 8 months ] [ Designated as safety issue: Yes ]number and severity of adverse events categorized according to CTC criteria version 4.0
|Study Start Date:||August 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
P16_37-63 peptide plus Montanide ISA-51 VG
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
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. Specifically, the present study aims at the following questions:
- Evaluation of potential toxicity of the vaccination with P16_37-63 -peptide
- Evaluation of the immune response in patients with advanced HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer before vaccination and after vaccination with P16_37-63.
In this context, the present study shall demonstrate whether application of P16_37-63 in a vaccination approach is associated with the induction of peptide-related toxicity. Hence, the study marks the first step towards the application of P16_37-63 in humans, as it provides information on the safety of P16_37-63 as vaccination agent for the first time. Moreover, the study shall provide initial information, whether vaccination with P16_37-63 can induce p16INK4a -specific immune responses in patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Thus, it shall provide information, whether P16_37-63 has the potential to elicit peptide-specific immune responses and therefore represent a suitable target for the induction of tumor antigen-specific immune responses in this population.
The present study marks an important milestone towards a potential application of P16_37-63 as therapeutic agent in the management of patients with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Long-term goal of this approach is to develop novel tools for the palliative and/or adjuvant therapy of patients with advanced advanced HPV- and p16INK4a -positive tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462838
|Frankfurt/Main, Germany, 60488|
|Principal Investigator:||Elke Jäger, Prof. Dr.||Krankenhaus Nordwest Frankfurt|