Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 7/22/2018 |
| Start Date: | November 2003 |
| End Date: | January 2010 |
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.
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.
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.
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.
DISEASE CHARACTERISTICS:
- Histologically confirmed cervical intraepithelial neoplasia (CIN2/3)
- Human papillomavirus-16-positive disease
PATIENT CHARACTERISTICS:
- Age: > 18
Other
- Not pregnant
- Immunocompetent
We found this trial at
1
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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