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A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)


N/A
18 Years
N/A
Open (Enrolling)
Female
HPV16+, Cervical Intraepithelial Neoplasia (CIN 2/3)

Thank you

Trial Information

A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)


Primary Objectives

- To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by
HPV16

- To evaluate the effect of vaccination on histology

- To compare immunogenicity of three different routes of administration: intradermal
(ID), intramuscular (IM), intralesional (IL).

Secondary Objectives:

- To evaluate changes in HPV viral load

- To evaluate the cellular immune response to vaccination

- To evaluate the humoral immune response to vaccination

- To evaluate local tissue immune response

- To correlate measures of immune response with clinical response

- To correlate measures of immune response with those observed in the preclinical model


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate feasibility and toxicity in women with CIN2/3 caused by HPV16

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Cornelia L Trimble, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J0866, NA_00020850

NCT ID:

NCT00988559

Start Date:

September 2009

Completion Date:

December 2014

Related Keywords:

  • HPV16+
  • Cervical Intraepithelial Neoplasia (CIN 2/3)
  • high grade cervical dysplasia
  • treatment vaccine
  • therapeutic
  • HPV
  • DNA vaccine
  • gene therapy
  • gene gun
  • pre-cancerous
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Johns Hopkins Outpatient CenterBaltimore, Maryland  21287
Johns Hopkins Bayview Medical CenterBaltimore, Maryland  21224