Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121173
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2005-07-19
Brief Title:
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase III Clinical Trial of pNGVL4a-SigE7 DetoxHSP70 for the Treatment of Patients With HPV 16 Cervical Intraepithelial Neoplasia 23 CIN23
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III 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
PURPOSE This phase III 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-SigE7detoxHSP70 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-SigE7detoxHSP70 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
Primary
Determine the feasibility and toxicity of pNGVL4a-SigE7detoxHSP70 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-SigE7detoxHSP70 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA105696 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0323 | None | None | None |
| JHOC-03-05-06-02 | OTHER | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |