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

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; (submitted: June 10, 2013)	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; (submitted: June 10, 2013)	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; (submitted: June 10, 2013)	70
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, Senior)
Accepts Healthy Volunteers	No
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
Study Sponsor ICMJE	Sidney Kimmel Comprehensive Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Cornelia L. Trimble, MD Sidney Kimmel Comprehensive Cancer Center
PRS Account	Sidney Kimmel Comprehensive Cancer Center
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP