Clinical Trial: Vaccine Therapy in Preventing Cervical Cancer in Patients with Cervical Intraepithelial Neoplasia

This study is currently recruiting patients.

Sponsors and Collaborators: Sidney Kimmel Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Condition Intervention Phase
Cervical Cancer
high-grade squamous intraepithelial lesion
 Drug: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
 Procedure: biological response modifier therapy
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I
Phase II

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase I/II Study of pNGVL4a-Sig/E7(Detox)/HSP70 DNA Vaccine in Preventing Cervical Cancer in Patients with Human Papillomavirus-16-Positive Grade 2 Or 3 Cervical Intraepithelial Neoplasia

Further Study Details: 



  • Determine changes in lesion size and HPV viral load in patients treated with this vaccine.
  • Determine the cellular, humoral, and local tissue immune responses in patients treated with this vaccine.
  • Correlate measures of immune response with clinical response in patients treated with this vaccine.
  • Correlate measures of immune response in patients treated with this vaccine with those observed in the preclinical model.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

  • Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine subcutaneously once in weeks 0, 4, and 8 in the absence of disease progression or unacceptable toxicity. Patients undergo colposcopy in week 8, 15 and 19 and a therapeutic loop electrosurgical excision procedure (LEEP) in week 15. Cohorts of patients receive escalating doses of vaccine until the safest dose is determined.
  • Phase II: Patients receive vaccine as in phase I but at the safest dose determined in phase I. Patients also undergo colposcopy and LEEP as in phase I. After completion of the study treatment, patients are followed annually for 15 years.

PROJECTED ACCRUAL: Approximately 150 patients (approximately 12 will be treated in phase I and 25 will be treated in phase II) will be accrued for this study.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both


  • Histologically confirmed cervical intraepithelial neoplasia
  • Grade 2 or 3 disease
  • Human papillomavirus-16-positive disease


  • Over 18

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Must be immunocompetent


  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior hysterectomy

Location and Contact Information

Please refer to this study by identifier  NCT00121173

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21287,  United States; Recruiting
Cornelia L. Trimble, MD  410-502-0512 

Study chairs or principal investigators

Cornelia L. Trimble, MD,  Study Chair,  Sidney Kimmel Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000439494; JHOC-J0323; JHOC-03-05-06-02
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005 Identifier:  NCT00121173
Health Authority: United States: Federal Government processed this record on 2005-07-26


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