Spots Global Cancer Trial Database for Cisplatin-based Chemotherapy Combined With P16_37-63 Peptide Vaccination in Patients With HPV-positive Cancers

Study Description

Brief Summary: The study will include 10 patients with HPV-associated ano-genital cancer (cervical, vulvar, vaginal, penile, anal) or HPV-associated head and neck cancer, who are planned to receive a cisplatin-based chemotherapy (alternatively a carboplatin-based chemotherapy may be selected by investigators choice). Patients will receive P16_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest period (1 cycle). The vaccination is to be started one week before the initiation or continuation of the cisplatin-based chemotherapy. Concurrent radiation is allowed and should be documented. The vaccination schedule will be repeated up to a total of 3 cycles (= 6 months) or until progression or intolerable toxicity. If chemotherapy is withheld (e.g. for toxicity), vaccination treatment can be continued.

Detailed Description: 10 patients with HPV- and p16INK4a-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer will be enrolled. The p16INK4a-peptide (p16INK4a-37-63, 100 mcg) mixed with MONTANIDE ISA-51 VG (0.3 ml) will be administered subcutaneously once weekly for four weeks, followed by a 4-week rest period (1 cycle). This schedule will be repeated for a total of 3 cycles (= 6 months) or until tumor progression or intolerable toxicity is documented. The first application will be done one week before chemotherapy initiation or continuation. Concurrent radiation is allowed and should be documented. If chemotherapy is withhold for toxicity, vaccination treatment can be continued. Patients will be seen at baseline/screening and at every visit for safety assessment until disease progression or discontinuation of trial therapy for other reasons. Immunological assessments will be made in all patients. The immunological assessment includes the delayed time hypersensitivity response (DTH) against the P16_37-63 peptide. Therefore in week 1, 9, 17 and 25, 30 mcg P16_37-63 peptide solution without MONTANIDE ISA-51 VG will be injected at a separate site from the vaccination site intradermally. Immunological responses are evaluated at baseline and after vaccination in weeks 9, 17 and 25 (ELISPOT) and in weeks 1, 3, 9, 11, 17, 19 and 25 (ELISA) and are compared to the antigen-specific immune response measured before vaccination (week 1). Radiological tumor assessment (CT, MRI) will be performed at baseline and then every 8 weeks (after every cycle). There will be a follow- up visit four weeks after the last vaccination for safety. Further follow-up regarding progression and death can be performed, e.g. via a phone call. Autoimmunity will be assessed every 8 weeks. Safety of the immunization will be analyzed as assessed by the number and severity of adverse events categorized according to CTC criteria

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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