Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00121173
First received: July 19, 2005
Last updated: June 10, 2013
Last verified: June 2013

July 19, 2005
June 10, 2013
November 2003
January 2010   (final data collection date for primary outcome measure)
  • Toxicity [ Time Frame: 01/2010 ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00121173 on ClinicalTrials.gov Archive Site
  • Changes in lesion size and human papillomavirus viral load [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]
  • Cellular, humoral, and local tissue immune responses [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]
  • Correlate measures of immune response with clinical response [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]
  • Correlate measures of immune response with the preclinical model [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
A Phase I/II Clinical Trial of pNGVL4a-Sig/E7 (Detox)/HSP70 for the Treatment of Patients With HPV 16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

RATIONALE: 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.

OBJECTIVES:

Primary

  • Determine the feasibility and toxicity of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in preventing cervical cancer in patients with human papillomavirus (HPV)-16-positive grade 2 or 3 cervical intraepithelial neoplasia.
  • Determine the effect of this vaccine on the histology of cervical tissue specimens from these patients.

Secondary

  • 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.

  • Phase I: 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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cervical Cancer
  • Precancerous Condition
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
  • Experimental: Low dose
    3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
    Intervention: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
  • Experimental: Intermediate dose
    3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
    Intervention: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
  • Experimental: High dose
    3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
    Intervention: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Trimble CL, Peng S, Kos F, Gravitt P, Viscidi R, Sugar E, Pardoll D, Wu TC. A phase I trial of a human papillomavirus DNA vaccine for HPV16+ cervical intraepithelial neoplasia 2/3. Clin Cancer Res. 2009 Jan 1;15(1):361-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
January 2010
January 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical intraepithelial neoplasia

    • Grade 2 or 3 disease
  • Human papillomavirus-16-positive disease

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior hysterectomy
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00121173
J0323 CDR0000439494, R21CA105696, P30CA006973, JHOC-J0323, JHOC-03-05-06-02
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Cornelia L. Trimble, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP