Cervical Cancer Clinical Trial
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)
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
| Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
| Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
| Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
| Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
| Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |