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
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 01/2010 ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: 01/2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: November 2003
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Experimental: Intermediate dose
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Experimental: High dose
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121173

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Cornelia L. Trimble, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00121173     History of Changes
Other Study ID Numbers: J0323 CDR0000439494, R21CA105696, P30CA006973, JHOC-J0323, JHOC-03-05-06-02
Study First Received: July 19, 2005
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 29, 2014