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

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ClinicalTrials.gov Identifier: NCT00121173

Recruitment Status : Completed

First Posted : July 21, 2005

Last Update Posted : June 12, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information

First Submitted Date ^ICMJE

July 19, 2005

First Posted Date ^ICMJE

July 21, 2005

Last Update Posted Date

June 12, 2013

Study Start Date ^ICMJE

November 2003

Actual Primary Completion Date

January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Toxicity [ Time Frame: 01/2010 ]
Efficacy [ Time Frame: 01/2010 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00121173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in lesion size and human papillomavirus viral load [ Time Frame: 01/2010 ]
Cellular, humoral, and local tissue immune responses [ Time Frame: 01/2010 ]
Correlate measures of immune response with clinical response [ Time Frame: 01/2010 ]
Correlate measures of immune response with the preclinical model [ Time Frame: 01/2010 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Condition ^ICMJE

Cervical Cancer
Precancerous Condition

Intervention ^ICMJE

Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Study Arms

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

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

January 2010

Actual Primary Completion Date

January 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00121173

Other Study ID Numbers ^ICMJE

J0323 CDR0000439494
R21CA105696 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0323
JHOC-03-05-06-02

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Sponsor ^ICMJE

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Cornelia L. Trimble, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

PRS Account

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Verification Date

June 2013

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

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