Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00121173
First received: July 19, 2005
Last updated: February 1, 2010
Last verified: November 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Precancerous Condition |
Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Toxicity [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in lesion size and human papillomavirus viral load [ Designated as safety issue: No ]
- Cellular, humoral, and local tissue immune responses [ Designated as safety issue: No ]
- Correlate measures of immune response with clinical response [ Designated as safety issue: No ]
- Correlate measures of immune response with the preclinical model [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2003 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121173
Locations
| 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
Investigators
| Study Chair: | Cornelia L. Trimble, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Cornelia Liu Trimble, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00121173 History of Changes |
| Other Study ID Numbers: | CDR0000439494, JHOC-J0323, JHOC-03-05-06-02 |
| Study First Received: | July 19, 2005 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013