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New treatment option for ASC-US
Official title Study of Treatment for HPV16+ ASC-US or LSIL
ClinicalTrials.gov ID: NCT03913117
What this study is testing
What is pNGVL4aCRTE6E7L2?
pNGVL4aCRTE6E7L2 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for asc-us.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, women only
You may be able to join if
- Patients with persistent (\>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)
- Patients whose cytologic samples are persistent (\>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other...
- Age ≥ 19 years
- Baseline Eastern Cooperative Oncology Group
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
You likely can't join if
- Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.
- Histologic evidence of CIN2+
- Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.
- Prior vaccination with any HPV antigen (prophylactic or therapeutic).
- Patients who are receiving any other investigational agents within 28 days prior to the first dose.
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure...
See the full eligibility criteria
- Patients with persistent (\>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)
- Patients whose cytologic samples are persistent (\>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test at study entry. Co-infections with HPV...
- Age ≥ 19 years
- Baseline Eastern Cooperative Oncology Group
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
- White blood cell count \> 3,000
- Absolute lymphocyte number \> 500
- Absolute neutrophil count \> 1,000
- Platelets \> 90,000
- Hemoglobulin \> 9
- Total bilirubin \<3 X the institutional limit of normal
- AST(SGOT)/ALT(SGPT) \<3 X the institutional limit of normal
- Creatinine \< 2.5X the institutional limit of normal
- Women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier) prior to study entry and for 3 months after study completion.
- Ability to understand and the willingness to sign a written informed consent document.
- Subject is able to adhere to the study visit schedule and other protocol requirements.
- Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.
- Histologic evidence of CIN2+
- Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.
- Prior vaccination with any HPV antigen (prophylactic or therapeutic).
- Patients who are receiving any other investigational agents within 28 days prior to the first dose.
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Patients with a history of autoimmune disease such as multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
- Patients with a history of allergic reactions attributed to compounds used in agent preparation.
- Patients who are pregnant or breast feeding.
- Patient with active or chronic infection of HIV, HCV, or HBV.
- Patients who have had a prior LEEP or cervical conization procedure.
- History of prior malignancy permitted if patient has been disease free for ≥ 5 years; however individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.
- Inability to understand or unwillingness to sign an informed consent document.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.