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Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN)


Phase 1
18 Years
45 Years
Not Enrolling
Female
Papillomavirus Infections

Thank you

Trial Information

Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN)


Inclusion Criteria:



- Written informed consent in accordance with institutional guidelines;

- Female 18-45 years of age;

- Post surgical (including LEEP and conization) or ablative treatment and a diagnosis
of CIN 2 or 3, while under physician care as per ASCCP guidelines (Appendix D);

- Normal ECG and normal laboratory values as judged by Grade 0-1 as per Toxicity
Grading Scale for Healthy Adults (Appendix C) for CBC, CPK, SMA-12 and urinalysis
evaluations done up to 30 days prior to administration of study treatment;

- Body mass index (BMI) ≤30 kg/m2;

- Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use
medically effective contraception (oral contraception, barrier methods, spermicide,
etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to 3 months
after the last injection (~6 months);

- Able and willing to comply with all study procedures.

Exclusion Criteria:

- Active infection with herpes simplex virus (HSV);

- Positive serological test for HIV virus, hepatitis C virus or Hepatitis B virus
surface antigen (HBsAg);

- Pregnant or breastfeeding subjects;

- Any concurrent condition requiring the continued use of systemic or topical steroids
(excluding inhaled and eye drop-containing corticosteroids) or the use of
immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks
prior to Day 1 of treatment;;

- Administration of any blood product within 3 months of enrollment;

- Administration of any vaccine within 6 weeks of enrollment;

- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of signing informed consent;

- Metal implants at the site of injection;

- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements;

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (i.e. infections disease) illness must
not be enrolled into this study;

- Any other conditions judged by the investigator that would limit the evaluation of a
subject.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of escalating doses of VGX-3100, administered by IM injection with EP to adult female subjects post surgical or ablative treatment of grade 2 or 3 CIN.

Outcome Time Frame:

Through Month 4

Safety Issue:

Yes

Principal Investigator

Christina Chu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

HPV001

NCT ID:

NCT00685412

Start Date:

May 2008

Completion Date:

March 2011

Related Keywords:

  • Papillomavirus Infections
  • CIN 2 or 3
  • cervical cancer
  • Cervical Intraepithelial Neoplasia
  • Papillomavirus Infections

Name

Location

University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Lyndhurst Gynecologic AssociatesWinston-Salem, North Carolina  27103
Laurel Highlands, OB/GYN, P.C.Hopwood, Pennsylvania  15445