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Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia

NCT00788164CompletedPHASE1INTERVENTIONAL

Summary

RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and to see how well it works when given with or without imiquimod in treating patients with grade 3 cervical intraepithelial neoplasia.

Key Facts

Lead Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

Start Date

2008-11-01

Completion Date

2023-08-01

Study Type

INTERVENTIONAL

Official Title

A Phase I Efficacy and Safety Study of HPV16-specific Therapeutic DNA-vaccinia Vaccination in Combination With Topical Imiquimod, in Patients With HPV16+ High Grade Cervical Dysplasia (CIN3)

Interventions

TA-HPVpNGVL4a-Sig/E7(detox)/HSP70 DNA vaccineimiquimod

Conditions

Cervical CancerPrecancerous ConditionHPV DiseaseHuman Papilomavirus

Eligibility

Age Range

18 Years+

Sex

FEMALE

DISEASE CHARACTERISTICS:

* Colposcopically and biopsy confirmed grade 3 cervical intraepithelial neoplasia

  * Human papillomavirus (HPV) 16-positive disease by PCR
* Measurable disease after diagnostic biopsy
* No concurrent adenocarcinoma in situ of the cervix

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use an effective form of contraception during study treatment
* Immunocompetent
* No concurrent malignancy, except for nonmelanoma skin lesions
* No serious concurrent disorder, including any of the following:

  * Active systemic infection
  * Autoimmune disease
  * Proven or suspected immunosuppressive disorder
  * Major medical illnesses of the cardiovascular or respiratory system
* No evidence or history of cardiac disease, including any of the following:

  * Congestive heart failure
  * Symptomatic arrhythmia not controlled by medication
  * Unstable angina
  * History of acute myocardial infarction or cerebrovascular accident within the past 6 months
* No history of severe allergy including eczema or other exfoliative skin disorder
* No active eczema within the past 12 months
* No concurrent skin conditions, including any of the following:

  * Burns
  * Traumatic or pruritic skin conditions
  * Open wounds
  * Unhealed surgical scars
* Patients and their close social, sexual, or domestic contacts may not have any of the following active skin diseases:

  * Psoriasis
  * Lichen planus
  * Sever acneiform rash
  * Impetigo
  * Varicella zoster
  * Sepsis
* No close social contact with children under 5 years old
* No close social or domestic contact with a pregnant woman
* No HIV seropositivity
* No allergy to eggs

PRIOR CONCURRENT THERAPY:

* No previous vaccination with vaccinia
* No immunosuppressive medication (i.e., steroid therapy or other immunosuppressive/immunomodulating drugs \[e.g., cyclosporine\]) within the past 2 months
* No investigational agent(s) within the past 6 months
* No concurrent participation in another experimental protocol

Outcome Measures

Primary Outcomes

Safety and tolerability as determined by number of participants with Serious Adverse Events

Presence of Serious Adverse Events (as defined by according to NCI CTCAE v3.0) or dose limiting toxicities related to the study drugs.

Time frame: 10 weeks from the first intervention

Secondary Outcomes

Change in histology (CIN3 or no CIN3) of biopsies between baseline and week 15

Absence of CIN3 as assessed by colposcopically directed biopsy at week 15

Time frame: 15 weeks from the date of the first intervention

Change in histology (CIN3 or no CIN3) of biopsies between baseline and week 28

Absence of CIN3 as assessed by colposcopically directed biopsy at week 28.

Time frame: 28 weeks from the date of the first intervention

Quantitative changes in cervical HPV viral load in exfoliated cell samples

HPV genotypes present at study entry which become undetectable during the study window

Time frame: 41 weeks from the date of the first intervention

Change in number of lesions by serial digital colposcopy from week 0 to week 15

Number of lesions that were present at baseline, then become undetectable by colposcopy at week 15

Time frame: Change from baseline to 15 weeks

Change in size of lesions by serial digital colposcopy from week 0 to week 15

Change in size of lesions from baseline to week 15.

Time frame: Change from baseline to 15 weeks

Characterization of peripheral and local tissue response to vaccination

Compare immune responses in the blood to local immune responses in the tissue for patients who receive the study intervention, from serially obtained peripheral blood specimens and on tissue samples from therapeutic resection

Time frame: 41 weeks

Correlation of immune response with clinical response

Compare immune responses in the blood with histologic regression of CIN3 to CIN1 or less

Time frame: 41 weeks

Correlation between measures of immune response and preclinical experimental data

Compare immune responses detected in patients who received the study intervention to those detected in the preclinical animal model.

Time frame: 41 weeks from the date of the first study intervention

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, United States

Linked Papers

2021-01-19

Development of DNA Vaccine Targeting E6 and E7 Proteins of Human Papillomavirus 16 (HPV16) and HPV18 for Immunotherapy in Combination with Recombinant Vaccinia Boost and PD-1 Antibody

Persistent expression of high-risk human papillomavirus (HPV) E6 and E7 is an obligate driver for several human malignancies, including cervical cancer, wherein HPV16 and HPV18 are the most common types. PD-1 antibody immunotherapy helps a subset of cervical cancer patients, and its efficacy might be improved by combination with active vaccination against E6 and/or E7.

Linked Investigators

Chien-Fu Hung

Richard B. S. Roden

T.-C. Wu