NCT00121173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

July 20, 2018

Completed
Last Updated

July 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6.2 years

First QC Date

July 19, 2005

Results QC Date

March 28, 2014

Last Update Submit

June 20, 2018

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (2)

  • Safety and Toxicity

    Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.

    for the duration of the study, and whenever possible, for an additional 5 years

  • Efficacy

    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.

    for the duration of the study, and whenever possible, for an additional 5 years

Secondary Outcomes (4)

  • Regression of CIN3 Lesions

    15 weeks

  • Number of Participants With T-cell Immune Responses in the Blood

    41 weeks

  • Number of Participants With Correlated Measures of Immune Response With Clinical Response

    9 months

  • Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model

    9 months

Study Arms (3)

Low dose

EXPERIMENTAL

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

Intermediate dose

EXPERIMENTAL

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

High dose

EXPERIMENTAL

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

Interventions

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccineBIOLOGICAL

recombinant DNA vaccine

High doseIntermediate doseLow dose

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed cervical intraepithelial neoplasia (CIN2/3) * Human papillomavirus-16-positive disease PATIENT CHARACTERISTICS: \- Age: \> 18 Other * Not pregnant * Immunocompetent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • 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. doi: 10.1158/1078-0432.CCR-08-1725.

    PMID: 19118066RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

The trial was completed, as planned.

Results Point of Contact

Title
Cornelia L. Trimble, MD
Organization
Johns Hopkins University
ctrimbl@jhmi.edu
410-502-0512

Study Officials

  • Cornelia L. Trimble, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 21, 2005

Study Start

November 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 20, 2018

Results First Posted

July 20, 2018

Record last verified: 2018-06

Locations

US(1)