Safety, efficacy and immunogenicity of HPV 16 E7 DNA vaccination in HPV related squamous cell cancer.

Withdrawn

Conditions: squamous cell cancer
cervical cancer
10038588

Registration Number: NL-OMON38905

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 35

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 <=< 2
Life expectancy of 3 months or more
No indiciation of an active infectious disease
No history of autoimmun disease or systemetic undercurrent diease which might affect immunocompetence
Evaluable disease
Adequate bonemarrow, renal function and live function
Willing and able to undergo the planned study procedures
Last chemotherapy or radiotherapy more than 4 weeks ago (if applicable)

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I<br /><br>* Toxicity of TTFC-E7SH.<br /><br>* Toxicity of prime-boost vaccine.<br /><br>* To exclude unacceptable toxicity.<br /><br><br /><br>Phase II<br /><br>* Immunogenicity of TTFC-E7SH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Phase I<br /><br>* Immunogenicity of TTFC-E7SH.<br /><br>* Immunogenicity of prime-boost vaccine.<br /><br><br /><br><br /><br>Phase II<br /><br>* Efficacy of TTFC-E7SH, HPV 16+ vs HPV 16-.</p><br>