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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00121173
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 2003
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose

3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals.

Genetic (recombinant DNA vaccine)

 Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
recombinant DNA vaccine
Experimental: Intermediate dose
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
 Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
recombinant DNA vaccine
Experimental: High dose
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
 Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
recombinant DNA vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Toxicity [ Time Frame: for the duration of the study, and whenever possible, for an additional 5 years ]
    Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.

  2. Efficacy [ Time Frame: for the duration of the study, and whenever possible, for an additional 5 years ]
    The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.


Secondary Outcome Measures :
  1. Regression of CIN3 Lesions [ Time Frame: 15 weeks ]
    Number of participants with absence of CIN3 lesions at week 15

  2. Number of Participants With T-cell Immune Responses in the Blood [ Time Frame: 41 weeks ]
    Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)

  3. Number of Participants With Correlated Measures of Immune Response With Clinical Response [ Time Frame: 9 months ]
    Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV

  4. Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model [ Time Frame: 9 months ]
    Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical intraepithelial neoplasia (CIN2/3)
  • Human papillomavirus-16-positive disease

PATIENT CHARACTERISTICS:

- Age: > 18

Other

  • Not pregnant
  • Immunocompetent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121173


Locations
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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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Cornelia L. Trimble, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Publications of Results:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00121173    
Other Study ID Numbers: J0323 CDR0000439494
R21CA105696 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0323
JHOC-03-05-06-02 ( Other Identifier: JHM IRB )
First Posted: July 21, 2005    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Neoplasms
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type