cervical cancer squamous cell cancer
Conditions
Interventions
TTFC-E7SH will be injected intradermally on days 0, 3 and 6 using a permanent
make up device, and boost vaccinations after 4 weeks (days 28, 31 and 34).
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: HPV positive squamous cell cancer of the cervix, penis, vagina, vulva or head and neck region (phase I) No options for curative treatment (phase I) HPV positive cancer of the cervix, of which at least 50% HPV16+ (phase II) Eligible for chemoradiation (phase II) Age above 18 years Performance state WHO
Exclusion criteria
Exclusion criteria: Severe cardiac, respiratory or metabolic disease Symptomatic brain metastases Use of steroids or other immunosuppressive drugs Use of oral anticoagulant drugs Other cancers Severe infections requiring antibiotics Lactation of pregnancy (if applicable) Not willing to take adequate contraceptive measures (if applicable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I * Toxicity of TTFC-E7SH. * Toxicity of prime-boost vaccine. * To exclude unacceptable toxicity. Phase II * Immunogenicity of TTFC-E7SH. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I * Immunogenicity of TTFC-E7SH. * Immunogenicity of prime-boost vaccine. Phase II * Efficacy of TTFC-E7SH, HPV 16+ vs HPV 16-. | — |
Countries
Netherlands
Outcome results
None listed