Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00988559
• Date of registration: 01/10/2009
• Primary sponsor: Sidney Kimmel Comprehensive Cancer Center
• Public title: Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
• Scientific title: A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
• Date of first enrolment: September 2009
• Target sample size: 39
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00988559
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Cornelia L Trimble, MD

• Name: Cornelia L Trimble, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with high grade cervical intraepithelial lesions (CIN2/3)

- patients whose lesions are HPV16+

- patients who are age 18 or older

- patients who are able to give informed consent

- patients who are immunocompetent

- patients who are not pregnant, committed to using adequate contraception if of
childbearing age

- patients who have a minimum hemoglobin level of 9

Exclusion Criteria:

- Patients with cytologic evidence of glandular dysplasia

- Patients with cytologic evidence of adenocarcinoma in situ

- Patients who are pregnant

- Patients with an active autoimmune disease

- Patients who are taking immunosuppressive medication

- Patients with concurrent malignancy except for nonmelanoma skin lesions

- Patients who have an allergy to gold.

- Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the
proposed site(s) of administration that might interfere with the interpretation of
local skin reactions.

- History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin
disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed
site of administration in the past 5 years.

- Patients who have an active autoimmune disease or history of autoimmune disease
requiring medical treatment with systemic immunosuppressants, including: inflammatory
bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis,
hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and
Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic
corticosteroids or routine use of inhaled steroids is acceptable

- Patients who have received prior chrysotherapy (administration of gold salts to treat
rheumatoid arthritis).

- Patients with a history of arterial or venous thrombosis

- Patients with non-healed wounds.

- Patients with a history of keloid formation ( ID delivery group only)

- Patients with a history of hepatitis B with persistent infection.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Intraepithelial Neoplasia (CIN 2/3)

HPV16+

Intervention(s)

Biological: DNA vaccination

Biological: intra-lesional vaccine administration

Biological: intramuscular vaccination

Device: Gene gun vaccine

Procedure: therapeutic resection of the lesion

Primary Outcome(s)

To evaluate feasibility and toxicity in women with CIN2/3 caused by HPV16 [Time Frame: 2 years]

Secondary Outcome(s)

To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), and intralesional (IL) [Time Frame: 2 years]

Secondary ID(s)

1R21CA128232

J0866, NA_00020850

P50CA098252

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

National Institutes of Health (NIH)