AzTrials
AzTrials

Cervical CancerPhase 1/2NCT00121173

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

A Phase 1/2 study testing pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in people with Cervical Cancer and Precancerous Condition, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Cervical Cancer, Precancerous Condition
What is being tested?
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Nov 2003to Jan 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Age: > 18

Other

  • Not pregnant
  • Immunocompetent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Medical subject headings
Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccineBiological

    recombinant DNA vaccine

Study groups in NCT00121173
Study groupRoleWhat they receive
Low doseExperimental3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals. Genetic (recombinant DNA vaccine)
Receives: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Intermediate doseExperimental3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
Receives: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
High doseExperimental3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
Receives: Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Toxicity

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

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

  2. 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.

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

Secondary outcomes (4)

  1. Regression of CIN3 Lesions

    Number of participants with absence of CIN3 lesions at week 15

    Measured: 15 weeks

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

    Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)

    Measured: 41 weeks

  3. Number of Participants With Correlated Measures of Immune Response With Clinical Response

    Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV

    Measured: 9 months

  4. Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model

    Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121173
Sponsor's protocol ID
J0323 CDR0000439494
Other IDs
R21CA105696, P30CA006973, JHOC-J0323, JHOC-03-05-06-02
Status last verified
Jun 2018
First submitted
19 Jul 2005
Last updated
20 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 19118066

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in people with Cervical Cancer and Precancerous Condition, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Toxicity (time frame: for the duration of the study, and whenever possible, for an additional 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in